isi kandungan | contents · Ø to ensure continuous mutual understanding and co-operation between...

1ANNUAL REPORT 2012

National Pharmaceutical Control Bureau

ISI KANDUNGAN | CONTENTS

1. Visi, Misi, Matlamat & Strategi | Vision, Mission, Objectives & Strategy

2. Perutusan Pengarah | Director’s Foreword Message

3. Pengurusan Tertinggi BPFK | NPCB’s Top Management

4. Sidang Pengarang | Editorial Board

5. Pengenalan: BPFK | Introduction: NPCB

6. Carta Organisasi | Organisational Chart

7. Piagam Pelanggan | Client’s Charter

8. Senarai Perjawatan | List of Posts

9. Jasamu Dikenang | Remembering Your Services

10. Anugerah Perkhidmatan Cemerlang | Excellent Service Awards

11. Pencapaian | Achievements

12. Pendaftaran Produk | Product Registration

13. Penilaian Protokol dan Data Validasi | Evaluation of Protocol and Validation of Data

14. Pengujian Sampel | Sample Testing

15. Pemeriksaan Premis | Inspection of Premises

16. Pelesenan | Licensing

17. Surveilans | Surveillance

18. Famarkovigilans | Pharmacovigilance

19. Kosmetik | Cosmetics

20. Variasi | Variation

21. Penyebaran Maklumat dan Latihan | Information Dissemination and Trainings

22. Laporan Kewangan | Financial Report

23. Cabaran | Challenges

24. Hala Tuju | The Way Forward

25. Aktiviti Sosial | Social Activities

26. Galeri | Gallery

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2LAPORAN TAHUNAN 2012Biro Pengawalan Farmaseutikal Kebangsaan

VISIBiro Pengawalan Farmaseutikal Kebangsaan sebagai pusat kecemerlangan unggul dalam bidang regulatori farmaseutikal demi menjamin kesihatan dan kesejahteraan insan sejagat

MISIBiro Pengawalan Farmaseutikal Kebangsaan akan memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui pelaksanaan undang-undang oleh tenaga kerja yang berketerampilan dan usahasama strategik ke arah peningkatan status kesihatan rakyat

VISIONThe National Pharmaceutical Control Bureau will be a centre of excellence on pharmaceutical regulatory matters to ensure the health and well-being of mankind

MISSIONThe National Pharmaceutical Control Bureau shall ensure the quality, efficacy and safety of pharmaceutical products through the implementation of relevant legislation by a competent workforce working together in strategic alliance towards improving the health of the people

VISI, MISI, MATLAMAT DAN STRATEGIVISION, MISSION, OBJECTIVE AND STRATEGIES

3ANNUAL REPORT 2012


OBJECTIVETo ensure that therapeutic substances approved for the local market are safe, effective and of quality and also to ensure that natural products and cosmetics approved are safe and of quality

STRATEGIESØTo ensure organisational efficiency and effectiveness

through modernisation and automation of the office, laboratory and registration systems, with regular review and improvement of services

ØTo strengthen enforcement activity of the related legislations

ØTo ensure continuous mutual understanding and co-operation between the regulatory bodies and the private sector through dialogues and guidance

ØTo upgrade personnel potential and expertiseØTo attain a dedicated and fully committed workforce

through motivation, appreciation, and appropriate remuneration

ØTo strengthen research activities and upgrade facilities for such purposes

ØTo create working environment conducive for the personnel to work as a team with a caring attitude whilst discharging their duties in a professional manner

MATLAMATMemastikan bahawa bahan-bahan terapeutik yang dibenarkan di pasaran tempatan adalah selamat, berkesan dan berkualiti, serta menentukan bahawa produk semulajadi dan kosmetik yang dibenarkan di pasaran adalah selamat dan berkualiti

STRATEGIØMemastikan kecekapan dan keberkesanan

organisasi melalui pemodenan dan automasi sistem-sistem pejabat, makmal dan pendaftaran, peninjauan serta penambahbaikan perkhidmatan secara berterusan

ØMemperkukuh aktiviti penguatkuasaan undang-undang berkaitan

ØMemastikan suasana kefahaman dua hala dan kerjasama berterusan sentiasa wujud antara pihak regulatori dengan sektor swasta melalui sesi dialog dan bimbingan

ØMeningkatkan potensi serta kepakaran warga kerjaØMewujudkan satu kumpulan tenaga kerja yang

berdedikasi dan penuh komitmen melalui motivasi, penghargaan serta ganjaran yang berpatutan

ØMempergiatkan aktiviti penyelidikan serta meningkatkan kemudahan-kemudahan bagi tujuan tersebut

ØMewujudkan satu suasana yang menggalakkan kerja secara berpasukan dengan sikap penyayang, serta melaksanakan tugas-tugas secara professional


Keperluan mengawal selia produk kesihatan telah meningkat dengan mendadak sejak kebelakangan ini sejajar dengan peningkatan kesedaran kesihatan di kalangan orang awam serta akses & pilihan terhadap produk-produk kesihatan yamg sangat meluas. Susulan itu, inovasi amat diperlukan untuk menangani segala cabaran dalam arena regulatori ke arah meningkatkan kesihatan dan kualiti hidup rakyat.

Tahun ini merupakan tahun yang amat mencabar di mana Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) telah meneruskan lagi langkah di peringkat global dengan adanya kerjasama teknikal dua hala bersama agensi regulatori luar. Selain pengukuhan kawalan regulatori bagi memastikan kualiti, keberkesanan dan keselamatan produk-produk kesihatan yang berdaftar di dalam negara, BPFK juga telah menyumbang dan memainkan peranan dalam merealisasikan wawasan kerajaan untuk menaik taraf kehidupan rakyat luar bandar menerusi projek Pusat Transformasi Luar Bandar.

Antara pencapaian penting dalam mengukuhkan sistem kawalan regulatori sedia ada adalah perlaksanaan keperluan bagi pematuhan kepada garis panduan PIC/S untuk pendaftaran semua produk farmaseutikal serta akreditasi pusat Bioequivalence (BE). Selaras dengan itu, BPFK telah memulakan pemeriksaan premis luar negara untuk memastikan fasiliti perkilangan tersebut patuh kepada keperluan GMP. BPFK juga menjalankan pemeriksaan ke atas fasiliti BE berpandukan garis panduan GLP dan GCP.

The demand for regulatory control of health products has surged over the past years in line with the growth in the public’s health awareness and the increased access & choices of these products. Innovations are crucial to manage current challenges in the global regulatory landscape towards improving the nation’s health and quality of life of its citizens.

This has been a challenging year for the National Pharmaceutical Control Bureau (NPCB) as we continue to step up in the global scene with bilateral technical cooperation with other regulatory agencies. Apart from strengthening regulatory control to ensure the quality, efficacy and safety of registered products in the country, the NPCB also participated in the realization of one of the government’s vision to improve the lifelihood of its citizens in the rural areas through our involvement in the Rural Transformation Centre (RTC) project.

Among the significant achievements in the stengthening of our regulatory system includes the implementation of the requirements for compliance to the PIC/S Guidelines for the registration of all pharmaceutical products and the accreditation of Bioequivalence (BE) centres. In line with this, NPCB has started foreign inspections to ensure compliance of manufacturing facilities overseas to GMP as well as inspection of BE providers according to the principles of GLP and GCP.

PERUTUSAN PENGARAH DIRECTOR’S FOREWORD

5ANNUAL REPORT 2012


In the international arena, NPCB signed their first Memorandum of Understanding (MoU) related to pharmaceutical regulatory matters with the Health Sciences Authority (HSA), Singapore in March 2012. This MoU will begin a new era of cooperation between the two regulatory agencies. With our increased emphasis on international collaboration, NPCB also participated in three technical bilateral meetings namely with the HSA, Singapore, the National Agency of Drug and Food Control (NADFC), Republic of Indonesia and the Food Drug Administration (FDA) of Thailand.

Malaysia hosted the 1st Technical Meeting on Development and Harmonisation of Standards on Pharmaceuticals and Vaccines (DHSPV) among OIC Member States which was held in Kuala Lumpur on 1-2 October 2012. This meeting which was jointly hosted with the Ministry of Science, Technology and Innovation (MOSTI) Malaysia was attended by representatives from the OIC Member States as well as international bodies.

NPCB is committed to continually improve the efficiency of work processes and its quality management system. As testimony to this commitment, in 2012 we have successfully maintained our MS ISO 9001:2008 certification, increased the scope of our MS ISO/IEC 17025:2005 accreditation as well as obtained 5S certification from the Malaysian Administrative Modernisation and Management Planning Unit (MAMPU).

All these achievements would not be possible without the support and commitment of our dedicated and talented employees. I would like to take this opportunity to extend my heartfelt gratitude and thanks to all staff of NPCB for their dedication and hard work in making this year a success. The coming years will provide new and everchanging challenges to be faced and overcomed. I therefore urge all members of NPCB to prepare and equip themselves so as to ensure that NPCB fulfills its mission and vision and plays its role in ensuring the health and wellbeing of the nation. I am convinced that with teamwork and commitment from its dedicated staff, NPCB will achieve greater success in the future.

Di peringkat antarabangsa pula, BPFK telah menandatangani Memorandum Persefahaman (MoU) pertama dengan Health Sciences Authority (HSA) Singapura, dalam bidang regulatori farmaseutikal pada bulan Mac 2012. Ini merupakan permulaan era baru dalam kerjasama di antara kedua-dua badan regulatori ini. Dengan peningkatan tumpuan kepada kolaborasi antarabangsa, BPFK juga telah mengambil bahagian dalam tiga Mesyuarat teknikal Dua Hala iaitu dengan Health Sciences Authority Singapura, Badan Pengawas Obat dan Makanan (BPOM), Republik Indonesia dan Thailand Food and Drug Administration (FDA).

Malaysia telah menjadi tuan rumah bagi Mesyuarat Teknikal Pembangunan dan Penyelarasan Standard Farmaseutikal dan Vaksin (DHSPV) Negara-negara Pertubuhan Kerjasama Islam (OIC) yang pertama yang diadakan di Kuala Lumpur pada 1-2 Oktober 2012. Mesyuarat tersebut yang dianjurkan bersama Kementerian Sains, Teknologi dan Inovasi (MOSTI), Malaysia telah dihadiri oleh wakil dari negara-negara anggota OIC serta badan-badan antarabangsa.

BPFK juga sentiasa berusaha ke arah meningkatkan kecekapan proses kerja serta sistem pengurusan kualiti sedia ada. Sebagai bukti komitmen tersebut, BPFK telah berjaya mengekalkan pensijilan MS ISO 9001:2008 dan memperluaskan skop akreditasi MS ISO / IEC 17025:2005, selain daripada mendapat pensijilan 5S daripada Unit Pemodenan Tadbiran dan Perancangan Pengurusan Malaysia (MAMPU).

Kejayaan-kejayaan ini tidak dapat dicapai tanpa sokongan dan iltizam anggota BPFK yang berbakat dan berdedikasi. Saya ingin mengambil kesempatan ini untuk mengucapkan terima kasih kepada semua anggota BPFK di atas ketekunan serta kesungguhan yang diberikan dalam mencapai kejayaan tahun ini. Walau bagaimanapun, masih terdapat pelbagai cabaran baru yang perlu diatasi pada tahun-tahun akan datang. Oleh yang demikian, saya menyeru agar semua anggota BPFK bersiap sedia bagi memastikan organisasi ini dapat memainkan peranannya dalam merealisasikan misi dan visi bagi menjamin kesihatan serta keselamatan rakyat. Saya yakin dengan adanya komitmen dan kerjasama padu di kalangan semua anggota, BPFK akan mencapai kejayaan yang lebih tinggi pada masa akan datang.


Mr. Tan Ann LingPengarah Regulatori FarmasiDirector of Pharmacy Regulatory

Dr. Tajuddin AkasahTimbalan Pengarah Pusat Kawalan KualitiDeputy Director of Centre for Quality Control

Mdm. Siti Aida AbdullahTimbalan Pengarah Pusat Pendaftaran ProdukDeputy Director of Centre for Product Registration

Mr. Sulaiman Haji AhmadTimbalan Pengarah Pusat Komplians dan PelesenanDeputy Director of Centre for Compliance and Licensing

Ms. Sameerah Shaikh Abd. RahmanTimbalan Pengarah Pusat Pasca Pendaftaran ProdukDeputy Director of Centre for Post-Registration of Product

Dr. Kamaruzaman SallehTimbalan Pengarah Pusat Kajian Produk BaruDeputy Director of Centre for Investigational New Product

Mr. Mohd Zaidie bin Hj. Che DinKetua Pusat PentadbiranHead of Centre for Administration

PENGURUSAN TERTINGGI BPFK | NPCB’S TOP MANAGEMENT

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7ANNUAL REPORT 2012


SIDANG PENGARANG | EDITORIAL BOARD

Depan | FrontKiri ke KananLeft to Right

• Ms. Lee yee Chen• Ms. Kogilam Uttumahran• Ms. Tan Su Yin• Ms. Nadiah Abd Manan• Mdm. Ng Jia Mean• Ms. Nurrina binti Zulkepli

Tidak Hadir | Absent• Y.Bhg. Datin Shantini Thevendran• Ms. Belinna Abu Bakar• Mr. Ahmad Kamal Ahmad• Mdm. Nurhidayah Baharuddin• Mdm. Nur Amani Shaari• Mdm. Rema Panickar• Mdm. Siti Ainul bt. Ahmad Sanusi

Belakang | BackKiri ke KananLeft to Right

• Mdm. Kon Ee Wen• Mr. Wayne Wong• Mr. Wang Wai Meng• Ms. Syuhadah Mohamed Hassan• Ms. Fadhilah binti Hasbullah


Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) merupakan sebuah agensi regulatori kerajaan di Malaysia yang bertanggungjawab dalam memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal serta kualiti dan keselamatan produk semulajadi dan kosmetik yang dipasarkan di Malaysia.

BPFK telah diiktiraf sebagai Pusat Kolaborasi bagi Kawalan Regulatori Farmaseutikal sejak Mei 1996 oleh Pertubuhan Kesihatan Sedunia (WHO). Dengan pengiktirafan ini, BPFK telah mengadakan pelbagai latihan dalam jaminan kualiti dan hal ehwal regulatori kepada delegasi-delegasi dari agensi regulatori ubat kebangsaan (NDRA) yang lain. Kolaborasi dengan WHO juga melibatkan pemonitoran farmakovigilans / laporan kesan advers ubat.

Di samping itu, BPFK telah diterima sebagai ahli ke-26 dalam Pharmaceutical Inspection Co-operation Scheme (PIC/S) pada 1 Januari 2002. Sejak itu, BPFK telah terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan program Jaminan Kualiti Antarabangsa.

Melalui BPFK, Malaysia telah diterima sebagai ahli penuh kepada Organisation for Economic and Development (OECD) Mutual Acceptance Data (MAD) bagi Amalan Makmal Baik (GLP). Data bukan klinikal yang dijalankan di bawah Program Pemonitoran Komplians GLP BPFK akan diterima oleh semua negara OECD dan bukan OECD yang mematuhi sistem MAD.

The National Pharmaceutical Control Bureau (NPCB) is a government agency that is responsible in regulating pharmaceutical, natural and cosmetic products in Malaysia. The NPCB ensures the quality, efficacy and safety of pharmaceutical products as well as the quality and safety of natural products and cosmetics marketed in Malaysia.

The NPCB is recognised by the World Health Organization (WHO) as a Collaborating Centre in the Regulatory Control of Pharmaceuticals since May 1996. With this recognition, the NPCB has provided training in the fields of pharmaceutical quality assurance and regulatory affairs to delegates from other National Drug Regulatory Agencies (NDRA). The collaboration with WHO also covers the monitoring of pharmacovigilance / Adverse Drug Reactions reports.

In addition, the NPCB successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002. Since then, NPCB has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance programmes.

Through NPCB, Malaysia has been accepted as full member of the Organisation for Economic and Development (OECD) Mutual Acceptance Data (MAD) for Good Laboratory Practice (GLP). The non-clinical data conducted under the NPCB GLP Compliance Monitoring Programme shall be accepted by all OECD countries and Non-OECD countries that adhere to MAD System.

PENGENALAN: BPFK | INTRODUCTION: NPCB

9ANNUAL REPORT 2012


Bagi memastikan mutu perkhidmatan yang lebih berkualiti, BPFK telah bekerja keras dalam menaiktarafkan Sistem Pengurusan Kualiti. Pensijilan dari SIRIM, iaitu MS ISO 9001:2000, telah digantikan dengan MS ISO 9001:2008. Selain itu, BPFK telah memperoleh akreditasi MS ISO 17025:2005 bagi Pusat Kawalan Kualiti (PKK) di bawah Skim Akreditasi Makmal Malaysia (SAMM) pada tahun 2010.

In order to improve the quality of its services, the NPCB continues to strive towards upgrading its Quality Management System. As a result, the NPCB has successfully upgraded its MS ISO certification from version MS ISO 9001:2000 to MS ISO 9001:2008. Furthermore, NPCB has obtained MS ISO 17025:2005 accreditation for Centre for Quality Control under the Malaysian Laboratory Accreditation Scheme (SAMM) in 2010.


CARTA ORAGANISASI | ORGANISATIONAL CHART

PUSAT PENDAFTARANPRODUKCENTRE FOR PRODUCT REGISTRATION

Seksyen Ubat TerapeutikTherapeutic Medicine Section

Seksyen Biologiks dan KomplementariBiologic and Complementary Section

Seksyen Koordinasi RegulatoriRegulatory Coordination Section

Seksyen Ubat VeterinarVeterinary Medicine Section

Seksyen Bahan Aktif Farmaseutikal (API)Active Pharmaceutical Ingredient (API) Section

PUSAT KOMPLIANS DAN PELESENANCENTRE FOR COMPLIANCE AND LICENSING

Seksyen Amalan Perkilangan Baik (Farmaseutikal)Good Manufacturing Practice Section (Pharmaceutical)

Seksyen Amalan Perkilangan Baik (Komplimentari)Good Manufacturing Practice Section (Complementary)

Seksyen Pelesenan dan PensijilanLicensing and Certification Section

Seksyen Amalan Pengedaran BaikGood Distribution Practice Section

Seksyen Kualiti dan Perkembangan IndustriQuality and Industrial Development Section

PUSAT KAWALAN KUALITICENTRE FOR QUALITY CONTROL

Seksyen Pengujian BiofarmaseutikalPharmaceutical Biology Testing Section

Seksyen Pengujian Produk Semulajadi

Pharmaceutical Chemistry Testing Section

Seksyen Pengujian Kimia Farmaseutikal

Sekyen PenyelidikanResearch and Development Section

Seksyen Penilaian Produk KajianInvestigational Product Evaluation Section

Seksyen Pemonitoran Keselamatan Produk KajianInvestigational Product Safety Monitoring SectionSeksyen Komplians GCPGood Clinical Practice (CGP) Compliance Section

Seksyen Komplians GLPGood Laboratory Practice (GLP) Compliance Section

Unit PembangunanDevelopment Unit

Unit PentadbiranAdministration Unit

Unit KewanganFinance Unit

Unit Pengurusan Aset / StorFinance Unit

Seksyen Surveilans & Aduan ProdukPharmacovigillance Section

Seksyen FamakovigilansSurveillance & Complaints Section

Seksyen VariasiVariations Section

Seksyen KosmetikCosmetic Section

Seksyen Koordinasi Kualiti dan Sumber ManusiaManpower and Quality Coordination Section

Seksyen Perhubungan & PolisiInterrelation and Policy Section

Seksyen ICTInformation Communication Technology (ICT) Section

Pengarah Regulatori FarmasiDirector of Pharmacy Regulatory

PUSAT KAJIAN PRODUK BARUCENTRE FOR INVESTIGATIONAL NEW PRODUCT

PUSAT PENTADBIRANCENTRE FOR ADMINISTRATION

PUSAT PASCA PENDAFTARAN PRODUKCENTRE FOR POST REGISTRATION

PUSAT PEMBANGUNAN ORGANISASICENTRE FOR ORGANISATIONAL DEVELOPMENT

Natural Product Testing Section

Seksyen Perkhimatan MakmalLaboratory Services Section

Seksyen Piawai Rujukan dan KualitiStandards and Quality Section Section

11ANNUAL REPORT 2012


PUSAT PENDAFTARANPRODUKCENTRE FOR PRODUCT REGISTRATION

Seksyen Ubat TerapeutikTherapeutic Medicine Section

Seksyen Biologiks dan KomplementariBiologic and Complementary Section

Seksyen Koordinasi RegulatoriRegulatory Coordination Section

Seksyen Ubat VeterinarVeterinary Medicine Section

Seksyen Bahan Aktif Farmaseutikal (API)Active Pharmaceutical Ingredient (API) Section

PUSAT KOMPLIANS DAN PELESENANCENTRE FOR COMPLIANCE AND LICENSING

Seksyen Amalan Perkilangan Baik (Farmaseutikal)Good Manufacturing Practice Section (Pharmaceutical)

Seksyen Amalan Perkilangan Baik (Komplimentari)Good Manufacturing Practice Section (Complementary)

Seksyen Pelesenan dan PensijilanLicensing and Certification Section

Seksyen Amalan Pengedaran BaikGood Distribution Practice Section

Seksyen Kualiti dan Perkembangan IndustriQuality and Industrial Development Section

PUSAT KAWALAN KUALITICENTRE FOR QUALITY CONTROL

Seksyen Pengujian BiofarmaseutikalPharmaceutical Biology Testing Section

Seksyen Pengujian Produk Semulajadi


Seksyen Pengujian Kimia Farmaseutikal

Sekyen PenyelidikanResearch and Development Section

Seksyen Penilaian Produk KajianInvestigational Product Evaluation Section

Seksyen Pemonitoran Keselamatan Produk KajianInvestigational Product Safety Monitoring SectionSeksyen Komplians GCPGood Clinical Practice (CGP) Compliance Section

Seksyen Komplians GLPGood Laboratory Practice (GLP) Compliance Section

Unit PembangunanDevelopment Unit

Unit PentadbiranAdministration Unit

Unit KewanganFinance Unit

Unit Pengurusan Aset / StorFinance Unit

Seksyen Surveilans & Aduan ProdukPharmacovigillance Section

Seksyen FamakovigilansSurveillance & Complaints Section

Seksyen VariasiVariations Section

Seksyen KosmetikCosmetic Section

Seksyen Koordinasi Kualiti dan Sumber ManusiaManpower and Quality Coordination Section

Seksyen Perhubungan & PolisiInterrelation and Policy Section

Seksyen ICTInformation Communication Technology (ICT) Section

Pengarah Regulatori FarmasiDirector of Pharmacy Regulatory

PUSAT KAJIAN PRODUK BARUCENTRE FOR INVESTIGATIONAL NEW PRODUCT

PUSAT PENTADBIRANCENTRE FOR ADMINISTRATION

PUSAT PASCA PENDAFTARAN PRODUKCENTRE FOR POST REGISTRATION

PUSAT PEMBANGUNAN ORGANISASICENTRE FOR ORGANISATIONAL DEVELOPMENT


Seksyen Perkhimatan MakmalLaboratory Services Section

Seksyen Piawai Rujukan dan KualitiStandards and Quality Section Section


PENDAFTARAN PRODUK MASAPenilaian Penuh• Menilai permohonan pendaftaran:

o Ubat preskripsi

o Ubat bukan preskripsi

o Ubat baru dan biological

210 hari bekerja*

210 hari bekerja*

245 hari bekerja*

Penilaian Ringkas • Menilai permohonan pendaftaran produk suplemen kesihatan dan produk

semulajadi yang mengandungi:

o Bahan aktif tunggal

o 2 atau lebih bahan aktif

• Pengeluaran notifikasi kosmetik

• Pertukaran pemegang pendaftaran

• Sijil Produk Farmaseutikal

• Pertukaran Tapak Pengilang

60 hari bekerja*

80 hari bekerja*

3 hari bekerja^

45 hari bekerja*

15 hari bekerja*

45 hari bekerja*

PELESENAN MASA• Pengeluaran lesen pengilang, pemborong dan pengimport

• Penilaian Permohonan Lesen Import untuk Percubaan Klinikal (CTIL) dan Kebenaran Mengilang untuk Percubaan Klinikal (CTX):

o Bagi produk yang melibatkan First-in-Man Study, produk biologi-kal dan Advance Therapy Medicinal Product (ATMP)

o Bagi produk-produk selain daripada yang disebutkan di atas

4 hari bekerja*

45 hari bekerja*

30 hari bekerja*

UJIAN MAKMAL MASA• Pengujian sampel bagi tujuan pendaftaran 65 hari bekerja#

*Setelah permohonan lengkap diterima

^Bagi permohonan yang mematuhi keperluan ASEAN Cosmetic Directive (ACD)

#Setelah sampel dan dokumen lengkap diterima

PIAGAM PELANGGAN



PRODUCT REGISTRATION DURATIONFull Evaluation• To evaluate application for registration of:

o Prescription drugs

o Non-prescription drugs

o New drugs and biological

210 working days*

210 working days*

245 working days*

Abridged Evaluation• To evalute application for registration of health supplements and tradition-

al products containing:

o Single active ingredient

o 2 or more active ingredients

• Issuance of cosmetic notification

• Change of registration holder

• Certificate of Pharmaceutical Product (CPP)

• Change of manufacturing site

60 working days*

80 working days*

3 working days^

45 working days*

15 working days*

45 working days*

LICENSING DURATION• Issuance of manufacturer’s, wholesaler’s and importer’s license

• Evaluation of import license application for Clinical Trial License (CTIL) and Clinical Trial Exemption (CTX):

o For products involving First-in-Man Study, biological products and Advance Therapy Medicinal Product (ATMP)

o For products other than stated above

4 working days*

45 working days*

30 working days*

LABORATORY TESTING DURATION• Sample testing for purpose of registration 65 working days#

*Upon receipt of complete application

^For applications fulfilling ASEAN Cosmetic Directive (ACD) requirements

#Upon receipt of sample and complete documentation

CLIENT’S CHARTER


JAWATAN POSITION

GRED GRADE

BIL JAWATANNO. OF

POSITION

PENGISIANFILLING

KEKOSONGANVACANCIES

Pengarah (JUSA C)Director (JUSA C) VU7 1 1 0

Pegawai Farmasi Gred U54/U52/U48/U44/U41Pharmacist GradeU54/U52/U48/U44/U41

U54/U52/U48/U44/U41 207 202 5

Pegawai Teknologi Maklumat Gred F41Information Technology Officer Grade F41

F41 1 1 0

Penolong Pegawai Farmasi Gred U36Assistant Pharmacist Grade U36 U36 2 2 0



Penolong Pegawai Teknologi Maklumat Gred F32Assistant Information Technology Officer Grade F32

F32 1 1 0

Penolong Pegawai Perangkawan Gred E32 Assistant Statistical Officer Grade E32

E32 1 1 0

Penolong Pegawai Tadbir Gred N36Assistant Administrative Officer Grade N36

N36 1 1 0

Penolong Pegawai Tadbir Gred N27 Assistant Administrative Officer Grade N27

N27 2 2 0

Setiausaha Pejabat Gred N27-N36Office Secretary Grade N27-N36

N27-N36 1 1 0

Setiausaha Pejabat Gred N27-N28Office Secretary Grade N27-N28

N27-N28 2 2 0

Pembantu Tadbir Gred N22Administrative Assistant Grade N22

N22 2 2 0

Pembantu Tadbir Gred N17Administrative Assistant Grade N17 N17 15 13 2

SENARAI PERJAWATAN / LIST OF POST



JAWATAN POSITION

GRED GRADE

BIL JAWATANNO. OF

POSITION

PENGISIANFILLING

KEKOSONGANVACANCIES

Pembantu Tadbir (Penyelenggaraan Stor) Gred N17Administrative Assistant (Store Management)Grade N17

N17 1 0 1

Pembantu Tadbir (Kewangan) Gred W22Administrative Assistant (Finance) Grade W22

W22 2 2 0

Pembantu Tadbir (Kewangan) Gred W17Administrative Assistant (Finance) Grade W17

W17 9 9 0

Pembantu Perpustakaan Gred S17/S22Library Assistant Grade S17/S22

S17/S22 1 1 0

Pegawai Khidmat Pelanggan N17 Customer Service Officer Grade N17 N17 2 2 0

Juruteknik Komputer Gred FT17Computer Technician Grade FT17 FT17 1 1 0

Pengawal Keselamatan Gred KP11Security Guard Grade KP11 KP11 3 3 0

Pembantu Am Pejabat Gred N4Office Assistant Grade N4

N4 1 0 1

Pembantu Am Pejabat Gred N1Office Assistant Grade N1

N1 4 3 1

Pembantu Perawatan Kesihatan Gred U12/U3Health Care Assistant Grade U12/U3

U12/U3 10 10 0

Pemandu Kenderaan Bermotor Gred R6/R3Motor Vehicle Driver Grade R6/R3

R6/R3 5 4 1

JumlahTOTAL 355 342 13


Pada tahun 2012, sejumlah 19 orang anggota telah berpindah ke tempat bertugas yang baru, meletak jawatan atau bersara. Kepada semua anggota yang telah meninggalkan BPFK, kami ingin mengucapkan selamat maju jaya. Segala perkhidmatan dan jasa bakti yang telah dicurahkan oleh semua kepada BPFK selama ini amatlah dihargai dan akan dikenang untuk selamanya.

In 2012, a total of 19 staff were transferred, resigned or retired. The NPCB would like to thank them and wish them all the best in their future undertakings. All their services as well as contributions to the NPCB are greatly appreciated and will be fondly remembered.

BILNO

NAMANAME

JAWATANPOSITION

GREDGRADE

TEMPAT BERTUKARTRANSFERRED TO

1. Nor hayati bt Hussein Pegawai FarmasiPharmacist U48 Jabatan Kesihatan Negeri Selangor

Selangor State Health Department

2. Fong Yin Yin Pegawai FarmasiPharmacist U44 Hospital Sultanah Hajah Kalsom

Sultanah Hajah Kalsom Hospital

3. Nisha a/p Sailes Kumas A. Patel Pegawai FarmasiPharmacist U44 Hospital Selayang

Selayang Hospital

4. Nor Azaini Suzila binti Zakariah Pegawai FarmasiPharmacist U44 Jabatan Kesihatan Negeri Kelantan

Kelantan State Health Department

5. Mohd Rashid bin Hassan Pegawai FarmasiPharmacist U41 Jabatan Kesihatan Negeri Kedah

Kedah State Health Department

6. Haslinda binti Rustam Afandi Pegawai FarmasiPharmacist U41 Jabatan Kesihatan Negeri Pahang

Pahang State Health Department

7. Soh Jau Rhen Pegawai FarmasiPharmacist U41 Pusat Kesihatan Daerah Petaling

Petaling District Health Centre

8. Mior Zamri bin Mior Ahmad Pen.Pegawai FarmasiAssistant Pharmacist U32 Jabatan Kesihatan Negeri Selangor

Selangor State Health Department

9. Adifah Nur bt. Adilah Pen.Pegawai FarmasiAssistant Pharmacist U29 Hospital Kuala Lumpur

Kuala Lumpur Hospital

10. Haslina binti Selamat Pen.Pegawai FarmasiAssistant Pharmacist U29 Hospital Kuala Lumpur

Kuala Lumpur Hospital

11. Zuraida binti Abu Bakar Pen.Pegawai FarmasiAssistant Pharmacist U29 Hospital Kuala Pilah

Kuala Pilah Hospital

12. Wan Nor Azuani bt Wan Ariffin Pen.Pegawai FarmasiAssistant Pharmacist U29 Hospital Putrajaya

Putrajaya Hospital

13. Mohd Tarmizi bin Dollah Pen.Pegawai FarmasiAssistant Pharmacist U29 Bahagian Perkhidmatan Farmasi

Pharmaceutical Services Division

JASAMU DIKENANG | REMEMBERING YOUR SERVICES



Senarai nama anggota BPFK yang telah bersara atau meletak jawatan pada tahun 2012:

NPCB staff whom retired or resigned in 2012:

BILNO

NAMANAME

JAWATANPOSITION

GREDGRADE

TEMPAT BERTUKARTRANSFERRED TO

14. Siti Ayunie Binti Fauzi Pen.Pegawai FarmasiAssistant Pharmacist U29

Klinik Kesihatan Tok Uban, Pasir Mas Tok Uban Health Klinik, Pasir Mas

15. Nurul Amin bt. Abu Seman Pen.Pegawai FarmasiAssistant Pharmacist U29 Jabatan Kesihatan Negeri Kedah

Kedah State Health Department

16. Junainah binti Mohd Omar Penolong Pegawai TadbirAssistant Administrative Officer N27 Jabatan Kerja Raya

Public Works Department

17. Intan Shazwani binti Azman Pembantu TadbirAdministrative Assistant N17 Hospital Bukit Mertajam

Bukit Mertajam Hospital

18. Mohd Faizal bin Hj Idris Pembantu TadbirAdministrative Assistant N17 Hospital Serdang

Serdang Hospital

19. Norriha binti Selaman Pembantu Tadbir KewanganAdministrative Assistant (Finance)

W17 Hospital Port DicksonPort Dickson Hospital

BILNO

NAMA NAME

JAWATANPOSITION

GREDGRADE

BERSARA / BERHENTIRETIRED / RESIGNED

1 Tan Eng Tat Pegawai FarmasiPharmacist U44 Berhenti

Resigned

2 Ho Chiew Yun Pegawai FarmasiPharmacist U44 Berhenti

Resigned

3 Lee Kwee Hoong Pegawai FarmasiPharmacist U44 Berhenti

Resigned

4 Chin Fui Fui Pegawai FarmasiPharmacist U44 Berhenti

Resigned

5 Muhammad Mazree bin Mo-hamed Mahidin

Pegawai FarmasiPharmacist U44 Berhenti

Resigned

6 Teng Su Yi Pegawai FarmasiPharmacist U44 Berhenti

Resigned

7 Chow Soon Yee Pegawai FarmasiPharmacist U44 Berhenti

Resigned


BILNO

NAMA NAME

JAWATANPOSITION

GREDGRADE

BERSARA / BERHENTIRETIRED / RESIGNED

8 Cheah Voon Yuen Pegawai FarmasiPharmacist U44 Berhenti

Resigned

9 Khoo Su-ann Pegawai FarmasiPharmacist U44 Berhenti

Resigned

10. Moo Kai Shing Pegawai FarmasiPharmacist U44 Berhenti

Resigned

11. Khoo Jeng Yih Pegawai FarmasiPharmacist U41 Berhenti

Resigned

12. Yong Yi Shaun Pegawai FarmasiPharmacist U41 Berhenti

Resigned

13. Soo Li Ping Pegawai FarmasiPharmacist U41 Berhenti

Resigned

14. Tan Kian Kuang Pegawai FarmasiPharmacist U41 Berhenti

Resigned

15. Khoo Nee Meng Pegawai FarmasiPharmacist U41 Berhenti

Resigned

16. Ooi Pui Ling Pegawai Farmasi Pharmacist U41 Berhenti Resigned

17. Talip bin Tawil Pen.Pegawai FarmasiAssistant Pharmacist U36 Bersara

Retired

18. Maimun Othman Pen.Pegawai FarmasiAssistant Pharmacist

U32 (KUP)

BersaraRetired

19. Adida Ab. Latif Pen.Pegawai FarmasiAssistant Pharmacist

U32 (KUP)

BersaraRetired

20. Mohd Khairul Anwar b. Mohd Shahidan

PemanduDriver R3

Pelepasan Jawatan Dgn Izin Discharged from position with permission

21. Daniel A/L Sinniah PemanduDriver R3 Bersara

Retired



BILNO

NAMANAME

JAWATANPOSITION

1 Datin Shantini Thevendran Pegawai Farmasi U54Pharmacist U54

2 Rokiah Binti Isahak Pegawai Farmasi U54Pharmacist U54

3 Dr. Noraida Binti Mohamad Zainoor Pegawai Farmasi U54Pharmacist U54

4 Somiyaton Binti Mohd Dahalan Pegawai Farmasi U44/U48Pharmacist U44/U48

5 Tan Chin Ling Pegawai Farmasi U41/U44Pharmacist U41/U44

6 Fadhilah Binti Hasbullah Pegawai Farmasi U41/U44Pharmacist U41/U44

7 Atikah Binti Shaharudin Pegawai Farmasi U41/U44Pharmacist U41/U44

8 Zeti Hulwani Binti Baba Pegawai Farmasi U41/U44Pharmacist U41/U44

9 Nafiza binti Mohd. Ismail Pegawai Farmasi U41/U44Pharmacist U41/U44

10 Siti Nor Rahizah Binti Abd. Razak Pegawai Farmasi U41/U44Pharmacist U41/U44

11 Ng Sheng Xyng Pegawai Farmasi U41/U44Pharmacist U41/U44

12 Evelyn Loh Yun Xi Pegawai Farmasi U41/U44Pharmacist U41/U44

13 Nurul Nashriq Binti Md. Hamsin Pegawai Farmasi U41/U44Pharmacist U41/U44

Anugerah Perkhidmatan Cemerlang | Excellent Service Awards

Pada tahun 2012, seramai 28 orang anggota BPFK telah diberikan Anugerah Perkhidmatan Cemerlang. Anugerah ini diberi sebagai tanda pengiktirafan jabatan dan kerajaan terhadap prestasi kerja yang cemerlang.

In 2012, a total of 28 NPCB staff was presented with the Excellent Service Award. The award was given as a gesture of appreciation for the outstanding performance.


BILNO

NAMANAME

JAWATANPOSITION

14 Chuah Su Yin Florence Pegawai Farmasi U41/U44Pharmacist U41/U44

15 Mokhzanni Bin Mustapa Pegawai Farmasi U41/U44Pharmacist U41/U44

16 Lim Kah Hun Penolong Pegawai Farmasi U32Assistant Pharmacist U32

17 Mohd Khairi Bin Mohammad Isa Penolong Pegawai Farmasi U29/U32Assistant Pharmacist U29/U32

18 Latifah Binti Mohd Tap Penolong Pegawai Farmasi U29/U32Assistant Pharmacist U29/U32

19 Zaini Bin Jamaludin Penolong Pegawai Farmasi U29/U32Assistant Pharmacist U29/U32

20 Noraidah Binti Othman Penolong Pegawai Farmasi U29/U32Assistant Pharmacist U29/U32

21 Mohd Firdaus Bin Mansor Penolong Pegawai Farmasi U29/U32Assistant Pharmacist U29/U32

22 Aminah Binti Jaafar Pembantu Tadbir (Kewangan) W22Administrative Assistant (Finance) Grade W22

23 Siti Norehan Binti Jaafar Pembantu Tadbir (P/O) N17Administrative Assistant (P/O) Grade N17

24 Norizan Binti Jantan Pembantu Tadbir (P/O) N17Administrative Assistant (P/O) Grade N17

25 Hamizah Binti Mohd Pembantu Tadbir (P/O) N17Administrative Assistant (P/O) Grade N17

26 Nur Suhaila Binti Jauhari Pembantu Tadbir (P/O) N17Administrative Assistant (P/O) Grade N17

27 Muhamad Syukri Bin Nordin Pemandu Kenderaan R3Motor Vehicle Driver R3

28 Gunawathy Ramadas Pembantu Perawatan Kesihatan U3Health Care Assistant U3



PENCAPAIAN ACHIEVEMENT


1. Malaysia dan Singapura telah berjaya menandatangani Memorandum of Understanding (MoU) berkaitan regulatori farmasi pada 28 Mac 2012. Ini merupakan satu pencapaian yang baru bagi kerjasama dua hala antara Malaysia dan Singapura dalam bidang farmaseutikal. Tujuan MoU tersebut adalah untuk mengukuhkan, menggalakkan serta membangunkan kerjasama antara Malaysia dan Singapura dalam regulatori farmasi untuk faedah bersama.

2. Mesyuarat Dua Hala:a) Susulan daripada MoU, Mesyuarat Teknikal Dua

Hala Pertama antara BPFK dan pihak Health Sciences Authority (HSA) Singapura telah diadakan pada 9 April 2012 di Kuala Lumpur. Delegasi dari kedua-dua buah negara telah mengadakan perbincangan kumpulan bersama. Persetujuan telah dicapai di mana kedua-dua pihak akan terus bekerjasama lalu meningkatkan hubungan kerja sedia ada yang rapat.

b) Mesyuarat Teknikal Dua Hala antara BPFK dan Badan Pengawas Obat dan Makanan (BPOM), Republik Indonesia telah diadakan pada 11 Jun 2012 di Kuala Lumpur. Beberapa isu tentang sistem regulatori semasa dan bidang kerjasama telah dibincangkan.

c) Mesyuarat Teknikal Dua Hala antara BPFK dan Thai FDA telah diadakan pada 2 Julai 2012 di Bangkok.

3. Mesyuarat Teknikal Pertama Pembangunan dan Penyelarasan Standard Farmaseutikal dan Vaksin Negara-negara Pertubuhan Kerjasama Islam (OIC) telah diadakan pada 1-2 Oktober 2012 di Kuala Lumpur. Mesyuarat tersebut yang dianjurkan bersama oleh Kementerian Sains, Teknologi dan Inovasi, Malaysia dan Kementerian Kesihatan Malaysia (dengan kolaborasi OIC General Secretariat) telah dihadiri oleh wakil dari negara-negara anggota OIC badan-badan antarabangsa. Mesyuarat ini telah diadakan sebagai inisiatif negara anggota OIC ke arah pengeluaran dan self-reliance bagi farmaseutikal dan vaksin.

1. On 28th March 2012, Malaysia and Singapore signed their first health sector Memorandum of Understanding (MoU) related to pharmaceutical regulatory matters. It was a new milestone in cooperation as both Malaysia and Singapore faced similar challenges in the pharmaceutical field. The objective was to strengthen, promote and develop pharmaceutical regulatory affairs cooperation between Malaysia and Singapore on the basis of equality and mutual benefit.

2. Bilateral Meetings:a) Following the signing of MoU, the 1st Technical

Bilateral Meeting between the NPCB and Health Sciences Authority (HSA) Singapore was in Kuala Lumpur held on 9th April 2012. Both delegations carried out a joint group discussion to discuss the areas of mutual cooperation. It was agreed that both authorities will continue to work together to bring about greater cooperation and to enhance the existing close working relationship.

b) Technical Bilateral Meeting between the NPCB and the National Agency of Drug and Food Control (NADFC), Republic of Indonesia was held in Kuala Lumpur on 11th June 2012. Several issues relevant to the current regulatory system and the possible areas of collaboration were discussed.

c) Technical Bilateral Meeting between the NPCB and the Thai Food Drug Administration (Thai FDA) was held in Bangkok on 2th July 2012.

3. The 1st Technical Meeting on Development and Harmonisation of Standards on Pharmaceuticals and Vaccines (DHSPV) among OIC Member States was held in Kuala Lumpur on 1-2 October 2012. The jointly hosted meeting (by the Ministry of Science, Technology and Innovation, Malaysia and the Ministry of Health, Malaysia in collaboration with the OIC General Secretariat) was attended by representatives from the OIC Member States as well as international bodies. It was held as an initiative of the OIC Member States towards production and self-sufficient / self-reliance of pharmaceuticals and vaccines.

PENCAPAIAN | ACHIEVEMENTS



4. BPFK juga terlibat secara aktif dalam projek Pusat Transformasi Luar Bandar (RTC) yang bertujuan untuk membantu pembangunan pengeluar kecil dan sederhana atau individu yang berminat untuk mengeluarkan ubat tradisional atau kosmetik bernotifikasi:

-RTC Gopeng (16 - 19 Februari 2012) -RTC Kelantan (2 - 5 Mei 2012) -RTC Melaka (7 - 9 November 2012)

5. Pada tahun 2012, BPFK telah melancarkan laman web / portal rasmi baru yang dilengkapi dengan layout baru yang mematuhi spesifikasi yang ditetapkan. Laman web baru tersebut telah direka supaya lebih mesra pengguna. Ia juga menyediakan akses mudah untuk garis panduan seperti DRGD.

6. Dalam usaha untuk memastikan kompetensi warga BPFK; pelbagai latihan, seminar, bengkel serta sesi Continuing Medical Education (CME) telah diadakan. Sekurang-kurangnya 40 markah CPD dan 7 hari berkursus perlu dicapai.

7. Had baru bagi vitamin dan mineral diperkenalkan bagi produk suplemen kesihatan pada 2012. Had ini telah ditetapkan berdasarkan formula yang dipersetujui oleh negara-negara anggota ASEAN.

8. Seksyen Surveilans dan Aduan Produk mengambil bahagian dan menyumbang dalam satu Jawatankuasa Penilaian Teknikal bagi mencadangkan produk yang dibekalkan melalui Approved Product Purchase List (APPL) dan Kontrak Pusat kepada semua institusi kerajaan, termasuk hospital dan klinik.

9. Tahun 2012 menyaksikan ulang tahun ke-25 penubuhan Jawatankuasa Penasihat Kesan Advers Ubat Kebangsaan (MADRAC). Sejak ia ditubuhkan pada tahun 1987, MADRAC telah memainkan peranan yang aktif dalam memastikan keselamatan ubat-ubatan di Malaysia melalui perbincangan, cadangan dan keputusan yang dibuat semasa mesyuarat yang diadakan setiap dua bulan.

4. NPCB is also actively involved in the following Rural Transformation Centre (RTC) project aimed to help develop small and medium manufacturers or individuals who are interested to manufacture traditional medicines or notified cosmetics:

- RTC Gopeng (16th - 19th February 2012)- RTC Kelantan (2nd - 5th May 2012)- RTC Malacca (7th - 9th November 2012)

5. In 2012, the NPCB launched their new official website / portal with layout that adheres to certain specifications. The new website was designed to be more user-friendly and informative. It also provides easy access to guidelines such as the DRGD.

6. In order to ensure the competency of NPCB staff, various trainings, seminars, workshops and Continuing Medical Education (CME) sessions were conducted. A minimum of 40 Continuing Professional Development (CPD) and 7 course-days (hari berkursus) were required.

7. The new limits for vitamins and minerals were introduced for health supplement products in 2012. The limits were set based on a formulation agreed upon by ASEAN member states.

8. Surveillance and Product Complaints Section participated and contributed in the Technical Evaluation Committee to recommend products that supplied via Approved Product Purchase List (APPL) or Central Contract to all government institutions, including hospitals and clinics.

9. The year 2012 witnessed the 25th anniversary of the establishment of the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC). Since it was started in 1987, MADRAC has played an active role in ensuring the safety of medicines in Malaysia through discussions, recommendations and decisions made during the bimonthly meetings.


10. Penambahan skop akreditasi pada tahun 2012:i. Pengesanan dan penentuan kehadiran

Hydroquinone dalam produk kosmetik (krim)ii. Ujian pengesanan logam berat (merkuri and

plumbum) dalam produk kosmetik iii. Ujian kontaminasi mikrob untuk produk

kosmetikiv. Ujian kontaminasi mikrob untuk produk

semulajadi berdasarkan BP 2012

11. BPFK adalah sekretariat dan ahli Kumpulan Teknikal untuk Pembangunan Monograf Herba Malaysia dan terlibat dalam :

a. Pembangunan metodologi pengujian untuk Monograf Herba Malaysia Jilid 3

b. Verifikasi pengujian bahan kasar untuk Monograf Herba Malaysia di bawah projek New Key Economic Area (NKEA)

12. Pada 24hb Mei 2012, Seksyen Komplians GLP dalam PKPB bersama-sama pusat-pusat lain dalam BPFK telah berjaya meneruskan akreditasi MS International Organisation for Standardisation (ISO) 9001 (Quality Management System) bagi tahun 2012.

13. BPFK telah membangunkan suatu tabung amanah bagi pemeriksaan pusat kajian BE luar negara untuk menyenangkan proses pemeriksaan. Yuran struktur sebanyak € 5,000 telah diluluskan juga bersama-sama dengan pembangunan tabung amanah tersebut.

14. Aktiviti pemeriksaan APB ke atas premis pengilang luar negara yang mengeluarkan produk-produk farmaseutikal akan diaktifkan semula pada tahun 2013 setelah tergendala sejak tahun 2011 berikutan keperluan memuktamadkan polisi berkaitan penanggungan kos pemeriksaan APB luar negara di peringkat KKM. Sebuah akaun amanah iaitu Akaun Amanah Penilaian, Pengiktirafan Akreditasi, dan Pemeriksaan Amalan Perkilangan Baik Kementerian Kesihatan Malaysia telah ditubuhkan bagi memastikan pemeriksaan APB luar negara dapat dijalankan dan produk farmaseutikal luar negara dapat didaftarkan di Malaysia.

10. Extension of accreditation scope in 2012:i. Detection and determination of Hydroquinone

in cosmetic products (cream)ii. Heavy metals testing (mercury and lead) in

cosmetic productsiii. Microbial contamination test for cosmetic

productsiv. Microbial contamination test for natural

products based on BP 2012

11. NPCB is the secretariat and member of Technical Committee for Development of Malaysian Herbal Monograph and involved in :

a. Development of testing methodologies for Malaysian Herbal Monograph Volume 3

b. Verification of raw material testing for Malaysian Herbal Monograph under the New Key Economic Area (NKEA) project

12. On 24th May 2012, GLP Compliance Section from CINP had joined other centres in NPCB in continuing MS International Organisation for Standardisation (ISO) 9001 (Quality Management System) accreditation for 2012.

13. NPCB had established a trust fund for the inspection of overseas bioequivalence (BE) centre to facilitate and make ease the process of inspection. The fee structure of € 5,000 had also been approved in line with the establishment of the trust fund.

14. GMP inspection activities on overseas manufacturer which produce pharmaceutical products will be reactivated in the year 2013 after a delay since year 2011 following the need to finalize policies at the Ministry of Health (MOH) level relating to costs of GMP inspections in foreign countries. A trust account, known as ‘Akaun Amanah Penilaian, Pengiktirafan Akreditasi dan Pemeriksaan Amalan Perkilangan Baik Kementerian Kesihatan Malaysia’ was setup to ensure GMP inspections in overseas can be conducted and overseas pharmaceutical products can be registered in Malaysia.



15. Although the number of license application has increased, the Client’s Charter for the processing of Manufacturer’s License, Import License and Wholesaler’s License was shortened from 10 days to 4 days starting 2012.

15. Walaupun secara umumnya bilangan permohonan lesen telah meningkat, Piagam Pelanggan tempoh pemprosesan permohonan Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong telah dipendekkan daripada 10 hari kepada 4 hari mulai 2012.


Mukasurat ini sengaja dibiarkan kosong.This page was intentionally left blank.



PENDAFTARAN PRODUKPRODUCT REGISTRATION


PENDAFTARAN PRODUK | PRODUCT REGISTRATION

Sebagai sekretariat kepada Pihak Berkuasa Kawalan Dadah (PBKD), BPFK berperanan dalam mengendalikan permohonan pendaftaran produk-produk entiti kimia baru / ubat baru, biologik, preskripsi, bukan preskripsi, suplemen kesihatan, semulajadi serta veterinar.

Mulai Januari 2011, semua permohonan pendaftaran produk perlu dihantar menerusi sistem atas talian (online) QUEST3 (menggantikan sistem QUEST2) termasuk permohonan bagi produk entiti kimia baru dan biologik yang telah diproses menggunakan sistem manual pada tahun-tahun sebelumnya.

Permohonan pendaftaran bagi semua produk farmaseutikal dinilai dari aspek keselamatan, keberkesanan dan kualiti manakala produk semulajadi dinilai dari aspek keselamatan dan kualiti produk. Setelah sesuatu produk selesai dinilai, ianya akan dibentangkan di dalam Mesyuarat Pihak Berkuasa Kawalan Dadah untuk keputusan status pendaftaran produk tersebut.

Sebahagian besar kualiti produk siap farmaseutikal bergantung kepada kualiti bahan aktif farmaseutikal (API) yang digunakan dalam formulasinya. Oleh itu, prosedur kerja yang dapat memastikan pembekal sentiasa menggunakan bahan aktif yang berkualiti dalam produk adalah penting dalam melindungi kesihatan awam. Melalui sistem piawaian penilaian dan pemeriksaan, pihak kementerian akan dapat memastikan bahawa semua ubat-ubatan farmaseutikal adalah selamat, berkesan dan berkualiti.

Kementerian Kesihatan Malaysia (KKM) telah menetapkan 1 Januari 2012 sebagai tarikh permulaan dalam mengawal selia API sebagai sebahagian daripada syarat permohonan pendaftaran produk. Kawalan ini meliputi produk yang dikilangkan di dalam negara dan produk yang diimport dari luar negara.

Sebanyak 12 mesyuarat PBKD telah diadakan pada tahun 2012 dengan sebanyak 1,211 permohonan dibentangkan untuk keputusan status pendaftaran dalam Mesyuarat Pihak Berkuasa Kawalan Dadah. Sejumlah 633 produk telah diluluskan untuk pendaftaran. Keputusan terperinci status penilaian produk adalah seperti berikut:

As the secretariat to the Drug Control Authority (DCA), NPCB plays a crucial role in processing of registration application for new chemical entity (NCE) / new drug, biologics, prescription, non-prescription, health supplements, natural as well as veterinary products.

Since January 2011, all registration applications have to be submitted via the online system known as QUEST3 (an upgraded version of QUEST2 system). These included applications for NCE and biologics that were processed manually in previous years.

Applications for pharmaceutical products are evaluated for safety, efficacy and quality where as traditional products are evaluated for their safety and quality. Once a product has completed the evaluation process, it will then be tabled to the DCA meeting for a decision on the application status of the product.

The quality of a finished pharmaceutical product is significantly dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper system of qualification of suppliers is necessary to ensure a constant sourcing of APIs of appropriate quality and to safeguard the public health interests. Through standardised quality assessment and inspection procedures, the Ministry will be able to ensure that all pharmaceutical drugs are safe, effective and of quality.

The Ministry of Health (MOH) had 1 st January 2012 as the

date of commencement for the regulatory control of API as part of the requirements in the product registration application. This covers both locally manufactured and imported products.

As many as 12 DCA meetings were conducted in 2012 with a total of 1,211 applications for product registration being reviewed by the DCA (for all categories of products). A total of 633 products were approved for registration. A detailed breakdown of the number of products reviewed is as below.



Jadual 1: Senarai Produk Entiti Kimia Baru yang diluluskan pendaftaran oleh PBKD bagi tahun 2012Table 1: List of New Chemical Entity Products Approved by the DCA in 2012

Bil.No

Nama ProdukProduct Name

1 Besivance (besifloxacin) Ophthalmic Suspension 0.6%

2 Gilenya 0.5mg Hard Capsule

3 Cozaar XQ 5/50mg TabletCozaar XQ 5/100mg Tablet

4 Resolor 1mg Film Coated TabletsResolor 2mg Film Coated Tablets

5 Ella Tablet 30mg

6 Victrelis 200mg Hard Capsules

7 Artesunate and Mefloquine Hydrochloride Tablets 25/55mgArtesunate and Mefloquine Hydrochloride Tablets 100/220mg

8 Levitra 10 Mg Orodispersible Tablets

9 Dicetel 50mg Film-Coated TabletDicetel 100mg Film-Coated Tablet

10 Mozobil 20 mg/ml solution for injection

11 Trajenta 5mg Film-Coated Tablets

12 Acuvail (Ketorolac Tromethamine Ophthalmic Solution) 0.45%

13 Azoren 20 mg/5 mg film-coated tablets

14 Azoren 40 mg/5 mg film-coated tabletsAzoren 40 mg/10 mg film-coated tablets

15 Targin Prolonged-Release Tablets 5mg/2.5mg

16 Targin Prolonged-Release Tablets 10mg/5mgTargin Prolonged-Release Tablets 20mg/10mgTargin Prolonged-Release Tablets 40mg/20mg

17Vimpat 50 mg film-coated tabletsVimpat 100 mg film-coated tabletsVimpat 150 mg film-coated tabletsVimpat 200 mg film-coated tablets

18 TS-ONE Capsule 20TS-ONE Capsule 25

19 Afinitor 2.5mg Tablet

20 Emend IV 150mg Powder for Injection Vial

21Somatuline Autogel 60mg, prolonged-release solution for injection in a pre-filled syringeSomatuline Autogel 90mg, prolonged-release solution for injection in a pre-filled syringeSomatuline Autogel 120mg, prolonged-release solution for injection in a pre-filled syringe

22 Zytiga 250mg Tablet

23 Halaven 0.44mg/Ml Solution For Injection

24 Vimpat 10 mg/ml solution for infusion


Bil.No


25 Xalkori 200mg Hard CapsulesXalkori 250mg Hard Capsules

26 Visanne 2mg Tablet

27Zenhale Pressurized Inhalation Suspension 50/5mcgZenhale Pressurized Inhalation Suspension 100/5mcgZenhale Pressurized Inhalation Suspension 200/5mcg

28Advagraf 0.5mg Prolonged-release hard capsulesAdvagraf 1mg Prolonged-release hard capsulesAdvagraf 5mg Prolonged-release hard capsules

29 CoPlavix 75/100mg Film-Coated Tablet

30 Omacor 1000 mg Soft Capsules

31 Ozurdex 700 Micrograms Intravitreal Implant In Applicator

32 Zinforo 600mg Powder For Concentrate For Solution For Infusion

Jadual 2: Senarai Produk Biologik yang diluluskan pendaftaran oleh PBKD pada tahun 2012Table 2: List of Biologics approved by the DCA in 2012

Bil.No


1Puregon Solution For Injection In Vials 50 IU/0.5mlPuregon Solution For Injection In Vials 100 IU/0.5mlPuregon Solution For Injection In Vials 150 IU/0.5ml

2 Prolia Solution For Injection 60mgProlia Solution For Injection 60mg Pre-Filled Syringe

3 Simponi 50mg (0.5ml) Solution For Injection In A Pre-Filled Syringe

4 Zarzio 30 MU/ 0.5 ml Solution For Injection Or Infusion In Pre-Filled SyringeZarzio 48 MU/ 0.5 ml Solution For Injection Or Infusion In Pre-Filled Syringe

5 Measles And Rubella Virus Vaccine Live, Attenuated (Freeze-Dried) 1 DosesMeasles And Rubella Virus Vaccine Live, Attenuated (Freeze-Dried) 10 Doses

6 Xgeva 120mg Solution for Injection

7 Betaferon Injection

8 I.V.-Globulin SN Inj. (50mg/ml)

11

Insuman Rapid 100 IU/ML Solution For Injection In A VialInsuman Rapid 100 IU/ML, 3ml Cartridges For OptipenInsuman Comb 25 100 IU/ML Suspension For Injection In A VialInsuman Comb 25 100 IU/ML, 3ml Catridges For OptipenInsuman Comb 30 100 IU/ML, Suspension For Injection In A VialInsuman Comb 30 100 IU/ML, 3ml Cartridges For OptipenInsuman Basal 100 IU/ml, Solution For Injection In A VialInsuman Basal 100 IU/ml, 3ml Cartridges For Optipen

12 Benlysta Powder For Solution For Infusion 120mgBenlysta Powder For Solution For Infusion 400mg

13 Shanchol, Killed Bivalent (O1 And O139) Whole Cell Oral Cholera Vaccine



a. Penerimaan Permohonan Pendaftaran Produk

Rajah 1 di atas menunjukkan penurunan dalam bilangan permohonan yang diterima dari tahun 2009 hingga tahun 2012. Jumlah kumulatif permohonan yang diterima sehingga akhir tahun 2012 adalah sebanyak 73,450 permohonan. Penurunan bilangan permohonan pendaftaran produk yang diterima adalah kerana setiap permohonan perlu disaring terlebih dahulu sebelum diluluskan untuk membuat pembayaran yuran pemprosesan. Setiap permohonan disaring di mana hanya permohonan yang lengkap akan diterima dan diluluskan untuk membuat pembayaran serta penilaian selanjutnya.

Pendaftaran produk veterinar bermula pada 1 Ogos 2007 bagi produk sedia ada di pasaran. Sehingga 2012, bilangan kumulatif permohonan pendaftaran yang diterima bagi produk veterinar adalah sebanyak 2,889 permohonan.

a. Applications Evaluated for Product Registration

Figure 1 shows a decline in the total number of registration applications received from 2009 to 2012. The cumulative number of applications received until the end of 2012 was 73,450. This decline in the number of applications processed could be attributed to the introduction of the screening process before an application is approved for payment. An application will have to be screened first and only complete application received will be approved for payment and subjected to further evaluation.

The registration of veterinary products commenced on 1st August 2007 for existing products in the market. As of 2012, the cumulative number of applications received for veterinary products was 2,889.

Rajah 1: Bilangan Permohonan yang Diterima Mengikut Kategori Produk (2008 - 2012)Figure 1: Number of Applications Received by Product Categories (2008-2012)


Merujuk kepada Rajah 2, dapat dilihat bahawa sebahagian besar daripada bilangan permohonan yang diterima adalah bagi produk preskripsi iaitu sebanyak 42%.

Figure 2 shows that a large percentage of applications received were for the registration of prescription products (42%).

Rajah 2: Bilangan Permohonan Pendaftaran yang Diterima Mengikut Kategori Produk 2012Figure 2: Number of Registration Applications Received based on Product Category 2012

Rajah 3: Taburan Produk yang Didaftarkan (2008-2012)Figure 3: Distribution of Products Registered (2008-2012)



b. Bilangan Produk yang Didaftarkan

Merujuk kepada Rajah 3, dapat dilihat bahawa terdapat peningkatan dalam jumlah produk berdaftar berbanding dengan jumlah permohonan yang diterima bagi produk veterinar, produk semulajadi dan produk preskripsi. Perbezaan ini adalah disebabkan oleh penilaian permohonan yang diterima pada tahun sebelumnya, iaitu penyelesaian penilaian permohonan yang diterima pada tahun lepas.

b. Number of Registered Products

From figure 3, there is an increase in the cumulative number of products registered compared to the total applications received for veterinary, natural and prescription products. This difference can be attributed to the evaluation of product applications received in the previous year i.e. clearing of backlog applications from previous years.

Rajah 4: Peratus Produk yang Didaftarkan Mengikut Kategori 2012Figure 4: Percentage of Products Registered Based on Category 2012

Rajah 4 menunjukkan peratusan bilangan produk yang didaftarkan mengikut kategori produk pada tahun 2012. 47% produk yang didaftarkan merupakan produk kategori semulajadi diikuti dengan 29% produk preskripsi, 13% produk suplemen kesihatan, 7% produk bukan preskripsi dan 4% produk veterinar.

Figure 4 shows the percentage of products registered in 2012 based on product category. 47 % of products registered were natural products followed by 29% prescription products, 13% health supplements, 7% non-prescription and 4% veterinary products.


Rajah 5: Bilangan Permohonan Pendaftaran yang Ditolak (2008-2012)Figure 5: Number of Registration Applications Rejected (2008-2012)

c. Bilangan Permohonan yang Ditolak

Boleh diperhatikan pada rajah 5, terdapat peningkatan dalam bilangan produk veterinar yang ditolak berbanding dengan tahun-tahun sebelumnya. Ini adalah kerana skop penilaian bagi kategori produk ini telah diperluaskan untuk merangkumi produk kategori suplemen kesihatan dan semulajadi. Kebanyakan permohonan yang diterima tidak dapat memenuhi keperluan pendaftaran.

Terdapat juga peningkatan dalam bilangan produk suplemen kesihatan yang ditolak. Ini boleh dikaitkan dengan paras baru bagi had vitamin dan mineral yang dikuatkuasakan selaras dengan had yang disyorkan oleh negara-negara ASEAN bagi produk vitamin dan mineral untuk produk-produk suplemen kesihatan.

c. Rejected Products

It can be observed in figure 5 that there is an increase in the number of veterinary products rejected as compared to the previous years. This is because the scope of evaluation for this category of products has expanded to health supplement and natural products and most applications received failed to fulfill the requirements.

There was also an increase in the number of rejected health supplement products. This can be attributed to the new limits for vitamin and minerals which were enforced based on the ASEAN countries safety limits for vitamin and minerals for health supplement products.



Rajah 6: Peratus Permohonan Pendaftaran yang Ditolak Mengikut Kategori Produk 2012Figure 6: Percentage of Registration Application Rejected Based on Category 2012

Rajah 7: Bilangan Produk yang Dibatal Mengikut Kategori Produk (2008-2012)Figure 7: Number of Products Cancelled Based on Product Category (2008-2012)

Rajah 6 menunjukkan bilangan produk yang ditolak bagi tahun 2012 mengikut kategori produk.

d. Bilangan Produk yang Dibatal / Digantung

Rajah 7 menunjukkan peningkatan yang mendadak kepada bilangan produk semulajadi yang dibatalkan pada tahun 2012 berbanding tahun-tahun sebelumnya. Sebab utama untuk pembatalan produk adalah penamatan pengilang kontrak dan kegagalan pengilang mematuhi keperluan amalan perkilangan yang baik (GMP).

Figure 6 shows the number of rejected products in 2012 based on product category.

d. Cancelled and Suspended Products

There was a tremendous increase in the number of natural products cancelled in 2012 as compared to previous years (Figure 7). The main reasons for the cancellation included termination of the contract manufacturer and failure of the manufacturer to comply with the Good Manufacturing Practice (GMP) requirements.

Semulajadi/Natural

Bukan PreskripsiNon Prescription

PreskripsiPrescription


Merujuk kepada Rajah 8, 12 produk preskripsi dan 13 produk semulajadi telah digantung pendaftaran pada tahun 2012. Alasan penggantungan termasuklah kegagalan mengemukakan laporan kajian bioekuivalens dalam tempoh yang ditetapkan bagi produk preskripsi dan status pengilang tempatan yang lemah status GMP bagi produk semulajadi.

Based on Figure 8, 12 prescription products and 13 natural products were suspended from registration in 2012. Reasons for the suspension of products included failure to submit bioequivalence study report within the specified time frame for prescription products and poor GMP status among local manufacturers for natural products.

Rajah 8:Bilangan Produk yang Digantung Mengikut Kategori Produk (2008-2012)Figure 8: Number of Products Suspended Based on Product Category (2008-2012)

Rajah 9: Peratusan Produk Preskripsi Berdaftar Mengikut Sumber Negara 2012Figure 9: Percentage of Registered Prescription Products Based on Source 2012



e. Sumber Utama Produk Berdaftar

Rajah 9, 10 dan 11 menunjukkan peratusan produk berdaftar mengikut sumber negara bagi tahun 2012. Produk tempatan merupakan sumber utama bagi produk berdaftar, manakala negara India merupakan sumber utama bagi produk preskripsi yang diimport. Kebanyakan produk bukan preskripsi diimport dari United States. Negara China kekal sebagai sumber utama bagi produk semulajadi pada tahun 2012 sebagaimana ditunjukkan dalam Rajah 11.

e. Main Source of Registered Products

Figure 9, 10 and 11 provide a graphic description for the percentages of registered products based on the country of origin in 2012. Local products contributed the most number of products registered for all categories of products. However, India topped the list for imported prescription product and United States for the imported non-prescription products. China maintained its position as the main source of imported natural products in 2012; as shown in Figure 11.

Rajah 10: Peratusan Produk Bukan Preskripsi Berdaftar Mengikut Sumber Negara 2012Figure 10: Percentage of Registered Non Prescription Products Based on Source 2012

Rajah 11: Peratusan Produk Semulajadi Berdaftar Mengikut Sumber Negara 2012Figure 11: Percentage of Registered Natural Products Based on Source 2012


Rajah 12: Bilangan Sijil Produk farmaseutikal yang Dikeluarkan(2008-2012)Figure 12: Number of Certificate of Pharmaceutical Products Issued (2008-2012)

Rajah 13: Pengeluaran Sijil Produk Farmaseutikal ke Negara-negara Utama 2012Figure 13: Issuance of Certificate of Pharmaceutical Product 2012

f. Aktiviti-aktiviti Lain yang Berkaitan dengan Pendaftaran Produk

i. Pengeluaran Sijil Produk Farmaseutikal

Rajah 12 menunjukkan jumlah pengeluaran Sijil Produk Farmaseutikal semakin menurun sejak tahun 2009. Dari jumlah 2,247 Sijil Produk Farmaseutikal yang telah dikeluarkan pada tahun 2012, 15% adalah bagi pengeksportan ke Brunei. Rajah 13 menunjukkan bahawa kebanyakan produk dieksport ke Negara ASEAN lain.

f. Other Activities Related to Product Registration

i. Issuance of Certificate of Pharmaceutical Product (CPP)Figure 12 shows a steady decline in the issuance of the number of certificate of pharmaceutical product since 2009. From the 2,247 certificates issued in 2012, 15% were for products exported to Brunei. Figure 13 shows that majority of exported products were to other ASEAN member states.



Rajah 14: Permohonan Pembaharuan Pendaftaran Produk yang diluluskan (2008-2012 )Figure 14: Number of Application Approved for Renewal of Product Registration (2008-2012)

ii. Pembaharuan Pendaftaran Produk

Bagi setiap produk berdaftar di Malaysia, pemohonan pembaharuan pendaftaran produk perlu dilakukan setiap lima (5) tahun Permohonan pembaharuan pendaftaran produk perlu dikemukakan oleh pemohon sekurang-kurangnya enam (6) bulan sebelum tarikh luput pendaftaran. Rajah 14 menunjukkan sebanyak 4,116 permohonan pembaharuan pendaftaran telah diluluskan pada tahun 2012.

Rajah 15 menunjukkan pecahan kategori produk yang telah diperbaharui pendaftaran bagi tahun 2012. 43% daripada jumlah keseluruhan pembaharuan untuk produk adalah kategori semulajadi.

ii. Renewal of Product Registration

The application for renewal of a registered product has to be done every five (5) years. Application for renewal should be submitted at least six (6) months before the registration status of the product expires. Figure 14 shows that a total of 4,116 applications for renewal of product registration had been approved in 2012.

Figure 15 provides a summary on the breakdown of product categories renewed for registration in 2012. 43% of the products renewed were natural products.

Rajah 15: Kategori Produk bagi Pembaharuan Pendaftaran 2012Figure 15: Registration Renewal Based on Product Category (2012)


Rajah 16: Bilangan Permohonan Pertukaran Pemegang Pendaftaran Produk yang diluluskan (2008-2012)Figure 16: Number of Application Approved for Change of Product Registration Holder (2008-2012)

iii. Pertukaran Pemegang Pendaftaran Produk

Bilangan permohonan untuk meluluskan pertukaran pemegang pendaftaran telah meningkat secara mendadak pada tahun 2012. Sebab utama pemohonan dikemukakan adalah kerana pengambilalihan dan penggabungan antara syarikat-syarikat multinasional. Berdasarkan jumlah keseluruhan kelulusan pada tahun 2012, 38% kelulusan adalah melibatkan produk kategori preskripsi, disusuli dengan produk bukan preskripsi sebanyak 34% dan 25% bagi produk semulajadi .

iii. Change of Product Registration Holder

As compared to previous years, there was a tremendous increase in the applications for change of the product registration holder. The main reason cited for the increment was acquisition and merging between multinational companies. From the total number of requests approved in 2012, 38% approvals were for prescription products followed by 34% for non prescription products and 25% for natural products.



Rajah 17: Verifikasi Status Pendaftaran Produk (2008-2012)Figure 17: Product Registration Verification Status (2008-2012)

iv. Verifikasi Status Pendaftaran Produk bagi Aktiviti Penguatkuasaan

Antara aktiviti Bahagian Penguatkuasa Farmasi adalah penguatkuasaan terhadap peraturan-peraturan di bawah Peraturan Kawalan Dadah dan Kosmetik 1984. Produk-produk yang dirampas perlu disahkan status pendaftaran oleh pihak BPFK sebelum tindakan undang-undang dapat diambil.

iv. Product Registration Status Verification for Enforcement Activities

The registration status of a product seized by the Pharmacy Enforcement Division under the Control of Drugs and Cosmetics Regulations 1984 would require verification by NPCB before any legal action could be taken.


Rajah 17 menunjukkan jumlah pertanyaan yang diterima untuk pengesahan status pendaftaran produk bagi tempoh 2008 - 2012. Berbanding dengan tahun 2011, jumlah pengesahan status pendaftaran telah meningkat dua kali ganda pada 2012. Pertanyaan paling tinggi diterima adalah daripada Cawangan Penguatkuasa Negeri Johor. Jumlah pertanyaan daripada Cawangan Penguatkuasa Negeri lain adalah seperti di Rajah 18.

Figure 17 shows the number of requests received for the verification of registration status of products for 2008 - 2012. Compared to 2011, the number of requests for product registration status verification had doubled. The most number of requests were from the Johor State Pharmacy Enforcement Division. The number of requests received from the other State Pharmacy Enforcement Divisions is shown in Figure 18.

Rajah 18: Taburan Verifikasi Status Pendaftaran Produk Mengikut Cawangan Penguatkuasa Farmasi Negeri 2012Figure 18: Distribution of Product Registration Status Verification Based on State Pharmacy Enforcement

Division 2012



v. Permohonan Tambahan indikasi bagi produk berdaftar (produk entiti kimia baru dan biologik sahaja)

Tambahan indikasi baru adalah ditakrifkan sebagai indikasi yang sebelumnya tidak diluluskan bagi suatu produk farmaseutikal yang berdaftar. Ini termasuk indikasi terapeutik baru atau indikasi bagi kumpulan umur baru seperti kanak-kanak serta tidak melibatkan sebarang perubahan ayat. Terdapat dua jenis penilaian bagi tambahan indikasi bergantung kepada kelulusan yang diberikan oleh negara rujukan. Pada tahun 2012, terdapat 18 dan 15 permohonan tambahan indikasi bagi produk entiti kimia baru dan biologik yang dibentangkan untuk kelulusan oleh Pihak Berkuasa Kawalan Dadah.

v. Additional Indication application of a registered products (for NCE and Biologics only)

New / additional indication is defined as an indication which is not initially approved for a registered pharmaceutical product. This shall include new therapeutic indication or indication for new age group, such as usage in children, and shall not include changing/ rephrasing of sentences. There are two (2) types of evaluation process available for a new/ additional indication application depending on the reference countries approval. In 2012, there were 18 and 15 additional indication applications for NCE and biologic products respectively tabled in the DCA meeting for approval.



PENILAIAN DATA VALIDASI EVALUATION OF VALIDATION DATA


Penilaian Data Validasi |Evaluation of Validation Data

Salah satu keperluan untuk pendaftaran produk ialah data validasi yang memuaskan untuk produk berkenaan. Penilaian data validasi diperlukan untuk memastikan kualiti dan tahap keselamatan sesuatu produk.

Untuk tahun 2012, Seksyen Perkhidmatan Makmal telah menerima 1,250 data validasi untuk penilaian. Rajah 1 menunjukkan bilangan protokol analisa dan data validasi yang dinilai dari tahun 2008 hingga 2012. Bilangan protokol analisa yang dinilai menurun secara drastik kerana terdapat semakan pada prosedur di mana pengujian sampel pra-pendaftran untuk produk farmaseutikal yang memerlukan protokol analisa telah diganti dengan penilaian data validasi. Berbanding tahun-tahun terdahulu, pada tahun 2012, penilaian protokol analisa telah dihentikan sepenuhnya.

Selain daripada itu, terdapat penurunan pada bilangan data validasi yang dinilai. Ini berlaku mungkin kerana proses menaik taraf sistem Quest2 kepada Quest3 di mana tempoh perubahan diperlukan oleh pengguna untuk menyesuaikan diri dengan sistem baru. Pihak syarikat juga memerlukan masa untuk menyediakan dokumen-dokumen data validasi yang memenuhi syarat.

One of the requirements for product registration is satisfactory validation data of related products. Evaluation of validation data is necessary to ensure the quality and safety of products.

In 2012, the Laboratory Services Section had received 1,250 validation data for evaluation. Figure 1 shows the number of protocol analysis and validation data evaluated from 2008 to 2012. The number of protocol analysis evaluated declined drastically due to the procedural review whereby testing of pre-registration samples for pharmaceuticals that require protocol analysis was replaced with evaluation of validation data. Compared to previous years, in 2012, evaluation of protocol analysis was completely discontinued.

On the other hand, there was a decreasing pattern on the number of validation data evaluated. This may be due to the system upgrade from Quest2 to Quest3 whereby a transition period was needed for users to adapt to the new system. Companies also needed time to prepare their validation data documents that satisfy the requirements.

Rajah 1: Bilangan penilaian protokol analisa dan data validasi dari tahun 2008 hingga 2012Figure 1: Number of Protocol Analysis and Validation Data evaluation for 2008 to 2012

1939

2233

1820

1612

1250

460

76

5

2

0 500 1000 1500 2000 2500

2008

2009

2010

2011

2012

Protocol Analysis

Validation Data

Tahun / Year

Bilangan /Numbers



PENGUJIAN SAMPEL SAMPLE TESTING


Pengujian Sampel | Sample Testing

Salah satu fungsi utama Pusat Kawalan Kualiti ialah menjalankan pengujian sampel. Pengujian sampel dijalankan bagi memastikan kualiti dan tahap keselamatan sesuatu produk. Ujian-ujian ini dijalankan berpandukan farmakopoeia antarabangsa, prosedur dalaman BPFK dan protokol analisa syarikat. Terdapat 3 seksyen di Pusat Kawalan Kualiti yang menjalankan pelbagai ujian berbeza ke atas kategori sampel yang berbeza. Seksyen-seksyen ini ialah Seksyen Pengujian Kimia Farmaseutikal, Seksyen Pengujian Biofarmaseutikal dan Seksyen Pengujian Produk Semulajadi. Sebahagian ujian yang dijalankan oleh seksyen-seksyen berlainan ini ditunjukkan dalam Rajah 1. Sampel-sampel yang diterima untuk pengujian pada tahun 2012 ditunjukkan dalam Rajah 2.

One of the main functions of Centre for Quality Control is sample testing. Sample testing is carried out to ensure the quality and safety of the products. These tests are conducted based on international pharmacopoeias, NPCB’s internal procedures and company’s protocol analysis. There are 3 sections in Centre for Quality Control conducting different tests on different sample categories. These sections are Pharmaceutical Chemistry Testing Section, Biopharmaceutical Testing Section and Natural Product Testing Section. Some of the tests conducted by different sections are shown in Figure 1. Samples received for testing in 2012 are shown in Figure 2.

Rajah 1: Ujian-ujian yang dijalankan mengikut seksyenFigure 1: Tests conducted according to sections

Seksyen PengujianKimia Farmaseutikal /


Seksyen PengujianBiofarmaseutikal / Biopharmaceutical

Testing Section

Seksyen Pengujian Produk Semulajadi /


• Pengujian kimia am / General chemistry testing

• Ujian cerakin / Assay test

• Ujian identifikasi / Identification test

• Ujian prestasi dosej / Dosage performance test

• Ujian had mikrob / Microbial limit test

• Ujian sterility / Sterility Test

• Cerakin mikrobiologi / Microbiological Assay

• Ujian endotoksin bakteria / Bacterial Endotoxin Test

• Ujian pengesanan logam berat / Heavy metal detection test

• Keseragaman berat / Uniformity of weight

• Ujian pengecaian / Disintegration test

• Ujian penyaringan campurpalsu / Adulterant screening test

Rajah 2 : Jenis-jenis sampel yang diterima untuk pengujian pada 2012Figure 2 : Types of sample received for testing in 2012

Pendaftaran / Registration · Preskripsi / Prescription· Semulajadi / Natural

Pengawasan / Surveillance · Preskripsi / Prescription· Bukan preskripsi / Non-prescription· Semulajadi / Natural· Kosmetik / Cosmetic

Penguatkuasa / Enforcement · Preskripsi / Prescription· Semulajadi / Natural· Kosmetik / Cosmetic

Aduan & Reaksi Advers Ubat / Complaints & Adverse Drug Reactions · Preskripsi / Prescription· Bukan preskripsi / Non-prescription· Semulajadi / Natural· Kosmetik / Cosmetic



Rajah 3: Jumlah Sampel yang Diterima Mengikut Kategori (2008 – 2012)Figure 3: Number of samples received based on category (2008 – 2012)

Rajah 3 menunjukkan jumlah sampel yang diterima mengikut kategori. Pada tahun 2012, sejumlah 2,922 sampel telah diterima untuk pengujian. Jumlah sampel yang diterima untuk pengujian menunjukkan trend menurun kerana pengujian sampel farmaseutikal pra-pendaftaran telah digantikan dengan penilaian data validasi dan juga pengujian sampel pos-pendaftaran pada tahun 2008. Selain itu, sampel daripada semua Cawangan Penguatkuasa Farmasi (CPF) kecuali CPF Kuala Lumpur dan CPF Selangor telah dihantar ke makmal forensik Bahagian Perkhidmatan Farmasi (BPF) bagi tujuan penyaringan. BPFK hanya menerima sampel dari semua CPF yang mana keputusan pengujian digunakan sebagai bukti mahkamah.

Figure 3 shows the breakdown of the samples received according to different categories. In 2012, a total of 2,922 samples were received for testing. The numbers of samples received for testing had declined over the years due to the fact that pre-registration testing of pharmaceutical samples were replaced by evaluation of analytical method validation data and post-registration testing in year 2008. Besides, samples from all State Pharmacy Enforcement Divisions (CPF) except CPF Kuala Lumpur and CPF Selangor were sent to Forensic Laboratory of Pharmaceutical Services Division for screening purposes. NPCB would only receive samples from any CPF if the result of the analysis is to be used as evidence in court.


Rajah 4: Jumlah sampel yang diuji mengikut kategori (2008 – 2012)Figure 4: Number of samples tested based on category (2008 – 2012)

Rajah 4 menunjukkan jumlah sampel yang diuji mengikut kategori sampel. Pada tahun 2012, sebanyak 2,769 sampel telah diuji. Terdapat penurunan sebanyak 12% daripada jumlah 3,143 sampel pada tahun 2011.

Figure 4 shows the breakdown of samples tested according to sample categories. In 2012, a total of 2,769 samples were tested. This was a reduction of 12% from 3,143 samples in 2011.

Jadual 1: Bilangan sampel yang tidak menepati spesifikasi, 2012Table 1: Number of samples with out of specification result, 2012

Bil. DiujiSamples tested

Bil. GagalFailed

samples

% Gagal% Failed

Sampel PendaftaranRegistration Sample

Preskripsi Prescription 2 0 0.0Bukan Preskripsi Non-prescription 0 0 0.0

Semulajadi Natural 645 62 9.6

Jumlah / Total 647 62 9.6

Sampel Pengawasan /Surveillance Sample


Semulajadi Natural 679 50 7.4Kosmetik Cosmetics 610 34 5.6

Veterinari Veterinary 0 0 0.0Jumlah / Total 1752 155 8.8



Sampel Aduan /Complaint Sample




Sampel Penguatkuasa/Enforcement Sample




Sampel ADR /ADR Sample



Veterinari Veterinary 0 0 0.0Jumlah / Total 65 15 23.1Jumlah Keseluruhan / OverallTotal 2738 366 13.4

Jadual 1 menunjukkan 13.4% sampel yang diuji didapati tidak menepati spesifikasi. Kebanyakannya adalah sampel yang diterima daripada aktiviti penguatkuasa farmasi dan pengawasan produk dalam pasaran.

Table 1 shows that 13.4% of the samples tested failed to meet the required specification. Most of these samples were received from enforcement activities and post marketing surveillance activities.

Rajah 5: Bilangan sampel produk semulajadi (tradisional) yang diuji dan dikesan bahan campur palsu (2008 – 2012)

Figure 5: Number of natural (traditional) samples tested and adulterated (2008 – 2012)


Rajah 5 menunjukkan peningkatan sebanyak 132.9% bilangan sampel produk semulajadi yang diuji pada tahun 2012 berbanding dengan tahun 2011. Daripada sejumlah 1987 sampel produk semulajadi yang disaring untuk pengesanan bahan campur palsu pada tahun 2012, 6.7% daripadanya didapati mengandungi bahan campur palsu.

Jadual 2 menunjukkan senarai bahan campur palsu yang dikesan dalam sampel produk semulajadi pada tahun 2012. Kebanyakan bahan campur palsu ini mempunyai indikasi berikut:

• Untuk kesihatan lelaki• Untuk mengurangkan berat badan

Figure 5 shows an increase of 132.9% of natural product samples tested in year 2012 as compared to year 2011. From a total of 1987 natural product samples screened for adulterants in 2012, 6.7% were found to be adulterated.

Table 2 shows the list of adulterants detected in natural product samples in the year 2012. Majority of these adulterants are of the below indications:

• For men’s health• For control/reduction of body weight

Jadual 2: Bahan-bahan campur palsu yang dikesan di dalam sampel produk semulajadi, 2012Table 2: List of Adulterants Detected in Natural Product Samples, 2012

Bahan-bahan Campur PalsuAdulterants Sampel Penguatkuasa

Enforcement SampleSampel PengawasanSurveillance Sample

Sampel PendaftaranRegistration Sample

Bil. ujian Number of

tests

% Gagal % Fail

Bil. ujianNumber of

tests

% Gagal % Fail

Bil. ujian Number of

tests

% Gagal % Fail

Ubat ED / Erectile Dysfunction (ED) Drugs

119 59.66 40 5 62 0

Steroid / Steroids 22 40.91 207 0.97 34 2.94

NSAIDs / NSAIDs 2 0 268 0.75 31 3.23

Antihistamin/ Antihistamines 6 66.67 110 0.91 66 7.58

Antidiabetik / Anti-diabetics 10 10 6 0 6 0

Agent pelangsing / Slimming Agents 412 62.14 125 0.08 45 0

Lain-lain / Others 32 96.88 149 8.05 22 13.64

Jumlah / Total 603 905 266



Bahan Piawai Rujukan | Reference Standards

Bahan piawai rujukan digunakan sebagai bahan perbandingan untuk pengesahan dan kuantifikasi bagi sesuatu bahan yang diuji. Ia merupakan aspek yang penting dalam pengujian sampel. Unit Piawai Rujukan ditubuhkan pada 1994 bagi menjalankan aktiviti-aktiviti yang melibatkan pembelian, pengeluaran, penyimpanan, pembekalan dan pengurusan bahan dan piawai rujukan.

Piawai rujukan tersebut juga dibekalkan kepada agensi-agensi kerajaan dan pengilang farmaseutikal di Malaysia selain kegunaannya di makmal BPFK. Rajah 6 menunjukkan pembekalan piawai rujukan telah menurun pada tahun 2012 berbanding 2011. Ini adalah disebabkan oleh kekurangan permintaan dari agensi-agensi kerajaan, pengilang farmaseutikal dan makmal BPFK.

Reference standard is used as a measurement base for confirmation and quantification of substance during quality control testing. This is a critical element in sample testing. The Reference Standard Unit which was established in 1994 is responsible for all activities pertaining to procurement, production, storage, distribution and handling of reference materials and standards.

Apart from utilisation in NPCB laboratory, these reference standards were also supplied to other government agencies and pharmaceutical industries in Malaysia. Figure 6 shows reduced supply of reference standards in 2012 compared to 2011 due reduction of request for reference standard from government agencies, private industries and NPCB laboratories.

Rajah 6: Bekalan piawai rujukan (2008-2012)Figure 6: Supply of reference standards (2008-2012)

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Piawai Rujukan kerja / sekunder BPFK disediakan dengan cara pemiawaian ‘Analytical Reference Material’ menggunakan piawai rujukan primer sebagai rujukan. Selain itu, BPFK juga bekerjasama dengan negara-negara ASEAN yang lain untuk menghasilkan Piawai Rujukan ASEAN. Rajah 7 menunjukkan bilangan piawai rujukan ASEAN dan BPFK yang disediakan dari tahun 2008 hingga 2012. Jumlah piawai rujukan yang dihasilkan pada tahun 2012 meningkat berbanding tahun 2011. Peningkatan ini adalah untuk memastikan pembekalan piawai rujukan adalah mencukupi untuk menampung keperluan.

NPCB Working/ Secondary Standard are produced by standardisation of certified reference materials against primary standards. Apart from this, NPCB collaborates with other ASEAN countries to produce ASEAN Reference Standards. Figure 7 shows an increase in the number of reference standards produced in 2012 compared to 2011. This is to ensure sufficient supply of reference standards to fulfill the demand for reference standards.

Rajah 7: Bilangan Piawai Rujukan yang DisediakanFigure 7: Number of Reference Standards Produced (ASEAN and NPCB, 2008-2012)



PEMERIKSAANINSPECTIONS


Pemeriksaan Premis |Inspections of Premises

Biro Pengawalan Farmesutikal Kebangsaan (BPFK) bertanggungjawab menjalankan pemeriksaan Amalan Perkilangan Baik (APB) ke atas premis pengilang keluaran berdaftar dan produk kosmetik bernotifikasi dalam memastikan pematuhan pengilang-pengilang tersebut terhadap keperluan garis panduan APB semasa.

Selain itu, BPFK telah memperkenalkan Garis Panduan Amalan Pengedaran Baik (AEB), Edisi Pertama bermula Januari tahun 2011. Perlaksanaan Garis Panduan AEB ini adalah bagi menggantikan penggunaan Garis Panduan Amalan Penstoran Baik (ASB) sejak Januari tahun 1995.

Tujuan garis panduan tersebut diperkenalkan adalah selaras dengan perkembangan keperluan regulatori masa kini di mana kawalan terhadap keadaan penstoran produk ubat berdaftar dan kosmetik bernotifikasi bukan sahaja melibatkan aspek penstoran sahaja, tetapi turut meliputi proses pengedaran sehingga ke pengguna akhir. Selain itu, proses pengedaran produk-produk ubat berdaftar dan kosmetik bernotifikasi berpotensi terdedah kepada risiko yang tidak diingini sekiranya aspek keselamatan, kualiti dan efikasi tidak dikekalkan sepanjang proses penstoran dan pengedaran sebelum tiba kepada pengguna akhir. BPFK, dengan kerjasama daripada Cawangan Penguatkuasa Farmasi (CPF) Negeri, juga bertanggungjawab memastikan pengimport dan pemborong keluaran berdaftar mematuhi keperluan Amalan Pengedaran Baik (AEB) semasa.

National Pharmaceutical Control Bureau (NPCB) is responsible to conduct Good Manufacturing Practice (GMP) inspections at manufacturing premise of registered products and notified cosmetic products to ensure compliance to the current GMP guideline.

NPCB has also introduced the Good Distribution Practice (GDP) Guideline, 1st edition, in January 2011. The implementation of this GDP guideline is to substitute the Good Storage Practice (GSP) guideline previously used since January 1995.

The introduction of this guideline is in line with the broadening of current regulatory requirements where control of storage conditions of registered products and notified cosmetics includes aspects of storage and distribution until it reaches the end user. Besides that, the distribution process of registered products and notified cosmetics are potentially exposed to risks if the aspects of quality, safety and efficacy of these products are not maintained throughout the storage and distribution before it reaches the end user. NPCB works in collaboration with Pharmacy Enforcement Division to ensure importers and wholesalers of registered products comply with the requirements of current GDP guideline.



Pemeriksaan Amalan Perkilangan Baik(APB) | Good Manufacturing Practice Inspections(GMP)

Sebanyak 299 pemeriksaan APB telah dijalankan pada tahun 2012.

Pemeriksaan APB yang dijalankan merangkumi pemeriksaan rutin dan bukan rutin ke atas premis pengilangan yang terdiri dari beberapa kategori seperti farmaseutikal, tradisional, kosmetik, veterinar, Bahan Aktif Farmaseutikal (API) dan lain-lain lagi. Daripada jumlah 299 pemeriksaan ini, sebanyak 45 pemeriksaan telah dijalankan ke atas premis farmaseutikal, 102 premis tradisional, 119 premis kosmetik dan 33 premis-premis lain seperti premis pengilang veterinar, Bahan Aktif Farmaseutikal (API) dan sel stem. Carta di bawah menunjukkan bilangan pemeriksaan yang telah dijalankan berdasarkan kategori premis pengilang.

In 2012, a total of 299 GMP inspections were conducted.

The GMP inspections comprises of routine and non-routine inspections of manufacturer premises from various categories such as pharmaceutical, traditional, cosmetics, veterinary, active pharmaceutical ingredient (API) and others. From the total 299 inspections, the number of inspections conducted in premises of cosmetics, traditional, pharmaceutical and others (veterinary, API, stem cells and etc.) are 119, 102, 45 and 33 respectively. The pie chart below shows the number of inspections based on category of manufacturer premises.

Rajah 1: Bilangan pemeriksaan yang telah dijalankan pada tahun 2012 berdasarkan kategori premis pengilangFigure 1: Number of inspections conducted in 2012 based on category of manufacturing premises

119

102

45

33

Kosmetik /CosmeticTradisional /TraditionalFarmaseutikal /Pharmaceutical

Rajah 2: Bilangan Pemeriksaan yang telah Dijalankan dari tahun 2005-2012Figure 2: Number of GMP inspections from year 2005 - 2012

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Pemeriksaan Amalan Pengedaran Baik (AEB) |Good Distribution Practice Inspection (GDP)

Pemeriksaan Amalan Makmal Baik (GLP) | Good Laboratory Practice Inspection (GLP)

BPFK Selaku Agensi Pemantau Pematuhan Kebangsaan (APPK) untuk GLPNPCB as the National Compliance Monitoring Authorities (CMAS) for GLP

Sepanjang tahun 2012, pemeriksaan AEB telah dijalankan ke atas 32 premis pengimport atau pemborong di sekitar Kuala Lumpur dan Selangor. Pemeriksaan AEB dijangka akan berkembang pada masa akan datang dengan adanya usaha dan langkah promosi yang giat dilaksanakan bagi meningkatkan kesedaran terhadap keperluan AEB kepada pihak yang berkaitan pada tahun 2013.

Pada 2012, BPFK telah menjalankan pemeriksaan ke atas tapak-tapak berikut:-

a. Non-Clinical Research Facility, Medicine Research Resource Centre, Institute of Medical Research (IMR) pada 8hb – 9hb Oktober 2012 (Pra-Pemeriksaan)

b. Info Kinetics Sdn. Bhd. pada 14hb -16hb Februari 2012 (Pemeriksaan)

c. Perbadanan Bioteknologi Melaka pada 7hb - 9hb Ogos 2012 (Pemeriksaan Surveilans).

Pemeriksaan Surveilans akan dijalankan setahun sekali untuk dua tahun yang pertama. Bagi tahun-tahun berikutnya, Pemeriksaan Surveilans akan dijalankan sekali setiap dua tahun selepas pemeriksaan yang terakhir.

Satu mesyuarat tahunan antara dua APPK, iaitu BPFK dan STANDARDS MALAYSIA telah diadakan pada 21hb September 2012 untuk membincangkan isu-isu berkaitan program pemantauan pematuhan GLP.

BPFK telah dijemput untuk memberi ceramah di dua seminar GLP dan satu bengkel GLP. Dua seminar tersebut telah diadakan di University of Malaya Bioequivalence and Testing Centre (UBAT) pada 10hb September 2012 dan Institut Farmaseutikal & Nutraseutikal Malaysia (IPharm) pada 3hb - 4hb September 2012. Manakala, bengkel tersebut telah diadakan di Pusat Penyelidikan Dadah dan Ubat-Ubatan, Universiti Sains Malaysia (USM) pada 18hb – 19hb Disember 2012.

In 2012, 32 GDP inspections were conducted on importer or wholesaler premises in Kuala Lumpur and Selangor. This practice is expected to expand in the future as continuous efforts and promotional activities will be carried out in 2013 to increase the awareness of relevant parties on the requirements of GDP.

In 2012, NPCB conducted inspection on the following sites:-

a. Non-Clinical Research Facility, Medicine Research Resource Centre, Institute of Medical Research (IMR) on 8th - 9th October 2012 (Pre-Inspection)

b. Info Kinetics Sdn. Bhd. on 14th -16th February 2012 (Inspection)

c. Melaka Biotechnology Corporation on 7th - 9th August 2012 (Surveillance Inspection).

Surveillance Inspections will be conducted annually for the first two years. For subsequent years, the surveillance inspections will be conducted once every two years from the date of last inspection.

An annual meeting between two CMAs, i.e. NPCB and STANDARDS MALAYSIA was held on 21st September 2012 to discuss various issues related to GLP Compliance Monitoring Programme.

NPCB was invited to be a speaker in two GLP seminars and one GLP workshop. The seminars were conducted at University of Malaya Bioequivalence and Testing Centre (UBAT) on 10th September 2012 and Malaysian Institute of Pharmaceuticals and Nutraceuticals (IPharm) on 3rd - 4th September 2012. The workshop was conducted at Centre for Drug Research, Universiti Sains Malaysia (USM) on 18th - 19th December 2012



Pemeriksaan Jawatankuasa Etika Inspection on Ethics Committee

Pemeriksaan Pusat Kajian Bioekuivalens (BE) | Inspection on Bioequivalence (BE) Centre

Tiga belas Jawatankuasa Etika telah berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD) menurut arahan yang dikeluarkan pada 12hb Jun 2007. Pada 2012, BPFK telah menjalankan pemeriksaan ke atas semua Jawatankuasa Etika tersebut untuk memastikan aktiviti yang berkaitan dengan penilaian kajian klinikal dari sudut etika adalah mematuhi prinsip-prinsip dalam GCP. Status pendaftaran jawatankuasa-jawatankuasa tersebut akan dikekalkan jika pemeriksaan adalah memuaskan.

BPFK telah menjalankan pemeriksaan ke atas empat pusat kajian BE tempatan berdasarkan prinsip-prinsip GCP bagi tapak klinikal dan prinsip-prinsip GLP bagi tapak bio-analitikal.

Pemeriksaan penuh pusat kajian BE yang merangkumi fasiliti klinikal dan bio-analitikal telah dijalankan ke atas pusat kajian BE tempatan seperti berikut:-

a. Info Kinetics Sdn. Bhd.b. Pusat Pengajian Sains Farmasi, USMc. University of Malaya Bioequivalence and

Testing Centre (UBAT) d. Pharmacy-HRSB BA/BE Centre, Pusat Pengajian

Sains Farmasi, USM.

Pemeriksaan tapak klinikal tambahan telah dijalankan pada tapak gleneagles Clinical Research Centre, Penang (Info Kinetics Sdn. Bhd.)

Sehingga kini, tiga daripada empat pusat kajian BE yang diperiksa termasuk tapak klinikal tambahan bagi Info Kinetics Sdn. Bhd. telah diakreditasi kecuali Pharmacy-HRSB BA/BE Centre, USM yang masih dalam peringkat corrective actions dan/atau preventive actions. Maklumat mengenai pusat-pusat kajian BE yang telah diakreditasi telah dimuatnaik dalam Program Komplians BPFK bagi Pusat Kajian BE di laman sesawang BPFK. Sijil akreditatsi yang sah selama tiga tahun telah pun dikeluarkan kepada pusat-pusat tersebut.

Thirteen Ethics Committees have been registered with Drug Control Authority (DCA) following a directive issued on 12th June 2007. In 2012, NPCB had carried out inspections on all the Ethics Committees to ensure that their ethical review related activities were in compliance to the Principles of GCP. Their registration status with the DCA will remain unchanged if the inspection was found satisfactory.

NPCB has conducted inspections on four local BE centres based on the Principles of GCP for the clinical site and the Principles of GLP for the bio-analytical site.

A full BE inspection which involved clinical and bio-analytical facilities were conducted on the following local BE centres:-

a. Info Kinetics Sdn. Bhd.,b. School of Pharmaceutical Sciences, USM,c. University of Malaya Bioequivalence and

Testing Centre (UBAT) andd. Pharmacy-HRSB BA/BE Centre, School of

Pharmaceutical Sciences, USM.

Inspection for additional clinical site was conducted on Gleneagles Clinical Research Centre, Penang (Info Kinetics Sdn. Bhd.).

To date, three out of four inspected BE centres including the additional clinical site for Info Kinetics Sdn. Bhd. has been accredited except Pharmacy-HRSB BA/BE Centre, USM which was still in the stage of corrective actions and/or preventive actions. The information of the accredited BE centres has been made publicly available on the NPCB websites as part of the NPCB Compliance Programme for BE Centre. An accreditation certificate which is valid for three years has been issued to those accredited centres.


Senarai Jawatankuasa Etika yang telah diperiksa:-

a. Medical Research Ethics Committee, Ministry of Health Malaysia (MREC, MOH)

b. Joint Ethics Committee of School of Pharmaceutical Sciences, USM– Hospital Lam Wah Ee on Clinical Studies (USM-LWE), Penang

c. Joint Penang Independent Ethics Committee (JPEC)d. Independent Ethics Committee, Sime Darby Medical

Centre (IECSDMC)e. International Medical University Ethics Committee

(IMUJC)f. Medical Ethics Committee, University Malaya

Medical Center (MEC, UMMC)g. Universiti Teknologi MARA (UiTM), Research Ethics

Committee h. International Islamic University Malaysia Research

Ethics Committee (IREC)i. Jawatankuasa Etika Penyelidikan, Universiti

Kebangsaan Malaysia (JEPUKM)j. Sunway Medical Centre Independent Research

Ethics Committee (SREC)k. Jawatankuasa Etika Institut Jantung Negara (IJNEC)l. Jawatankuasa Etika Universiti untuk Penyelidikan

melibatkan Manusia, Universiti Putra Malaysia (JKEUPM)

m. Jawatankuasa Etika Penyelidikan (Manusia), Universiti Sains Malaysia (JEPeM)

Untuk memastikan pematuhan kepada prinsip GCP secara berterusan, BPFK akan menjalankan pemeriksaan ke atas semua Jawatankuasa Etika yang berdaftar sekali setiap dua tahun.

List of Ethics Committees that were inspected:-

a. Medical Research Ethics Committee, Ministry of Health Malaysia (MREC, MOH)

b. Joint Ethics Committee of School of Pharmaceutical Sciences, USM– Hospital Lam Wah Ee on Clinical Studies (USM-LWE), Penang

c. Joint Penang Independent Ethics Committee (JPEC)d. Independent Ethics Committee, Sime Darby Medical

Centre (IECSDMC)e. International Medical University Ethics Committee

(IMUJC)f. Medical Ethics Committee, University Malaya

Medical Center (MEC, UMMC)g. Universiti Teknologi MARA (UiTM), Research Ethics

Committee h. International Islamic University Malaysia Research

Ethics Committee (IREC)i. Jawatankuasa Etika Penyelidikan, Universiti

Kebangsaan Malaysia (JEPUKM)j. Sunway Medical Centre Independent Research

Ethics Committee (SREC)k. Jawatankuasa Etika Institut Jantung Negara (IJNEC)l. Jawatankuasa Etika Universiti untuk Penyelidikan

melibatkan Manusia, Universiti Putra Malaysia (JKEUPM)

m. Jawatankuasa Etika Penyelidikan (Manusia), Universiti Sains Malaysia (JEPeM)

In order to ensure continuous compliance of the Ethics Committees to the Principle of GCP, NPCB is committed to conduct an inspection to all registered Ethics Committees once every two years.



PELESENANLICENSING


Pelesenan Licensing

BPFK bertanggungjawab dalam aktiviti pelesenan premis pengilang, pengimport dan pemborong keluaran berdaftar. Ini selaras dengan definisi Lesen Pengilang, Mengimport dan Pemborong Keluaran Berdaftar yang tertakluk di bawah Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 (CDCR 1984) adalah seperti dalam jadual di bawah :

Pengeluaran Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar adalah berdasarkan peruntukan Peraturan 12 Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984.

Pada tahun 2012, sebanyak 1,832 lesen telah dikeluarkan yang meliputi 278 Lesen Pengilang, 410 Lesen Mengimport dan 1,144 Lesen Pemborong (Rajah 3). Ini merupakan satu peningkatan (9.9%) berbanding tahun 2011 di mana hanya 1,667 lesen dikeluarkan.

NPCB is also responsible in licensing of manufacturers, importers and wholesalers of registered products. This is in line with the definition of Manufacturer, Import and Wholesale Licenses of registered products subject to the Control of Drugs and Cosmetics Regulations (CDCR) 1984 as per the table below:

The issuance of Manufacturer’s License, Import License and Wholesaler’s License is based on Regulation 12 of the Control of Drugs and Cosmetics Regulation 1984.

In 2012, 1,832 licenses were issued consisting of 278 Manufacturer’s License, 410 Import License and 1,144 Wholesaler’s License (Figure 3). This is an increase (9.9%) compared to the year 2011 where only 1,667 licenses were issued.

LesenLicense

DefinisiDefinition

PengilangManufacturer

Lesen yang memberi kuasa kepada pemegang lesen untuk mengilang produk berdaftar di premis dan menjual secara borong atau membekal produk tersebut.License to allow manufacturing, sales by wholesale or supply of registered products.

MengimportImport

Lesen yang memberi kuasa kepada pemegang lesen untuk mengimport dan menjual secara borong atau membekal keluaran berdaftar dari premis pengimport.License to allow importation and sales by wholesale or supply of registered products.

PemborongWholesaler

Lesen yang memberi kuasa kepada pemegang lesen untuk menjual secara borong atau membekal keluaran berdaftar dari alamat premis yang telah ditetapkan di dalam lesen tersebut.License to allow sales by wholesale or supply of registered products from the address stipulated in the license.



Pada tahun 2012, Pusat Kajian Produk Baru telah menilai sebanyak 110 protokol baru bagi percubaan klinikal di Malaysia untuk produk farmaseutikal, produk biologikal, produk bioteknologi, vaksin, herbal, supplemen dan lain-lain. Selain itu, pusat ini juga telah menilai 15 produk tidak berdaftar yang dikilangkan di Malaysia untuk tujuan kajian bioekuivalen. Tambahan pula, terdapat 213 pemohonan variasi yang meliputi tambahan kuantiti produk, tambahan pusat penyelidikan, tambahan atau penukaran pintu masuk pengimportan, penukaran pemohon, pemanjangan tempoh luput produk kajian, tambahan atau penukaran tapak pengilang atau pembungkus, penukaran penyelidik utama, pembaharuan Lesen Import Percubaan Klinikal dan lain-lain.

Selain itu, sebanyak 564 permohonan untuk memasukkan keluaran berdaftar ke dalam senarai keluaran telah diproses sepanjang tahun 2012. Jumlah keluaran berdaftar yang terlibat adalah sebanyak 2,615. Senarai Keluaran (tambahan) ini dikeluarkan berdasarkan permohonan yang dikemukakan khususnya apabila terdapat produk yang baru didaftarkan.

In 2012, Centre for Investigational New Product had evaluated a total of 110 new applications to conduct clinical trials on pharmaceutical, biological, biotechnology, vaccine, herbal, health supplements products and others in Malaysia. Besides, this centre had also reviewed 15 CTX applications to manufacture unregistered products locally for bioequivalence study. In addition, there were 213 variation applications being processed in year 2012. Among the variation applications received were additional quantity, additional trial sites, change or additional entry ports, manufacturer or repacker, change of investigator, CTIL renewal, and others.

Besides, 564 applications to include registered product into the release list was processed throughout the year 2012. A total of 2,615 registered products were involved. Additional list is issued based on the application submitted when the products are newly registered.

Rajah 3: Jumlah Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong dikeluarkanFigure 3: Number of Manufacturing License, Import License and Wholesaler’s Licenses Issued

Pengeluaran Lesen Import Percubaan Klinikal (CTIL), Permit Mengilang Produk Tidak Berdaftar (CTX) Dan Permohonan VariasiIssuance of Clinical Trial Import Licence (CTIL), Permit To Manufacture (CTX) And Variation Application


Hasil daripada penilaian protokol di atas, sebanyak 282 Lesen Import Percubaan Klinikal, 15 kebenaran Mengilang produk tidak berdaftar dan 213 kelulusan permohonan variasi telah dikeluarkan seperti yang ditunjukkan dalam graf di bawah.

From the evaluation done, 282 CTIL, 15 CTX and 213 variations were being issued as shown in the graph below.

Rajah 4: Jumlah Permohonan lesen Import Percubaan Klinikal (CTIL), Kebenaran Mengilang (CTX) dan Variasi (2008-2012)

Figure 4: Number of Application for Clinical Trial Import License (CTIL), Clinical Trial Exemption (CTX) and Variation (2008-2012)



SURVEILANSSURVEILLANCE


Surveilans Surveillance

Objektif utama aktiviti surveilans di bawah Program Pengawasan Mutu Produk Berdaftar/Kosmetik Bernotifikasi adalah bagi memantau kualiti produk-produk berdaftar/bernotifikasi yang dipasarkan di Malaysia dan memastikan komplians terhadap spesifikasi atau piawaian yang telah ditetapkan oleh Kementerian Kesihatan Malaysia.

Persampelan Produk

Sebanyak 2,890 produk diperolehi pada tahun 2012 berbanding tahun sebelumnya iaitu 3,284 produk pada tahun 2011. Penurunan ini adalah kerana ketiadaan produk semasa pensampelan dijalankan. Pencapaian aktiviti persampelan dari tahun 2008-2012 ditunjukkan dalam Rajah 1. Pecahan kategori produk yang dipantau bagi tahun 2012 adalah seperti berikut: kosmetik, 1,447 (50.07%), produk semulajadi, 690 (23.88%), produk preskripsi, 489 (16.92%), produk suplemen kesihatan, 141 (4.88%), dan produk bukan preskripsi, 123 (4.26%).

Pemantauan Kepatuhan Keperluan Pelabelan

Kesemua produk yang disampel akan disemak pelabelannya bagi memastikan ia mematuhi keperluan pelabelan seperti mana yang telah ditetapkan oleh Pihak Berkuasa Kawalan Dadah. Dari sejumlah 3,401 label produk yang disemak, sebanyak 2,088 (61.39%) amaran dan 53 (1.56%) arahan panggil balik telah dikeluarkan bagi produk yang tidak mematuhi keperluan pelabelan. Maklumat hasil pemeriksaan label/sisip bungkusan bagi tahun 2012 secara terperinci adalah seperti Jadual 1 berikut.

The objectives of surveillance activities under the Post-Marketing Surveillance Programme are to monitor the quality of the registered products/notified cosmetics placed on the market and to ensure their compliance with the specifications or standards set by the Ministry of Health Malaysia

Product Sampling

A total of 2,890 products were sampled in 2012 as compared to 3,284 products in 2011. This is due to unavailability of products during sampling. Achievement of the sampling activities from 2008-2012 is shown in Figure 1. The breakdown of product categories that are monitored for the year 2012 are as follows: cosmetics, 1,447 (50.07%), natural products, 690 (23.88%), prescription products, 489 (16.92%), health supplements, 141 (4.88%) and non-prescription products, 123 (4.26%).

Labelling Compliance Monitoring

All products that have been sampled were inspected to ensure compliance with the labeling requirements as specified by the Drug Control Authority. From a total of 3,401 product labels that had been inspected, 2,088 (61.39%) warnings and 53 (1.56%) recall instructions had been issued for products that did not comply with labeling requirements. Detailed information on the results of inspection of the label/package inserts for 2012 is shown in Table 1.

Rajah 1: Bilangan produk yang disampel tahun 2006-2012Figure 1: Number of products sampled year 2006-2012



Pemantauan Kualiti Produk

Produk-produk yang diterima akan dihantar ke Pusat Kawalan Kualiti untuk pengujian makmal. Sejumlah 1,677 produk telah siap dianalisa pada tahun 2012, di mana sebanyak 1,476 (88.01%) telah lulus ujian makmal, manakala baki 128 produk (7.63%) telah gagal ujian makmal dan selebihnya 73 produk (4.35%) didapati tidak mematuhi piawai tatacara ujian yang ditetapkan. Pecahan produk yang gagal ujian makmal pada tahun 2012 mengikut kategori adalah seperti berikut: produk semulajadi, 66 (51.56%), produk preskripsi, 54 (42.19%), kosmetik, 42 (32.81%), produk bukan preskripsi, 29 (22.66%) dan produk suplemen kesihatan, 10 (7.81%). Laporan pengujian produk dari tahun 2006-2012 ditunjukkan pada Rajah 2.

Product Quality Monitoring

The sampled products were sent to the Centre for Quality Control for laboratory testing. There were 1,677 products analysed in 2012, of which 1,476 (88.01%) passed the testing, while 128 products (7.63%) failed laboratory testing and the other remaining 73 products (4.35%) were not compliant to the current standard of analytical method. Breakdown of products that failed laboratory testing in 2012 by product category as follows: natural products, 66 (51.56%), prescription products, 54 (42.19%), cosmetics, 42 (32.81%), non-prescription products, 29 (22.66%), health supplements, 10 (7.81%). Reports on product testing from year 2006-2012 is shown in Figure 2.

Jadual 1: Keputusan pemeriksaan label/sisip bungkusan mengikut kategori produk bagi tahun 2012Table 1: Results of inspection of the label / package inserts by product category for year 2012

Kategori produk Product Category

LulusPass

AmaranWarning

Arahan Panggil balik

Recall

Jumlah disemakTotal Inspected

Preskripsi Prescription 475 (98.14%) 9 (1.86%) 0 (0.00 %) 484

Bukan PreskripsiNon-Prescription 114 (86.36%) 18 (13.64%) 0 (0.00 %) 132

Suplemen KesihatanHealth Supplements 66 (76.74%) 18 (20.93%) 2 (2.33%) 86

SemulajadiNatural Products 226 (48.92%) 185 (40.04%) 51 (11.04%) 462

KosmetikCosmetics 379 (16.94%) 1,858 (83.06%) 0 (0.00 %) 2,237

Jumlah keseluruhanGrand total 1,260 (37.05%) 2,088 (61.39%) 53 (1.56%) 3,401


Rajah 2: Keputusan pengujian produk dari tahun 2006-2012Figure 2: Results of laboratory testing from 2006-2012

2242

2563

18211968

21151910

1476

168 232142 140 129 185 201*

0

500

1000

1500

2000

2500

3000

2006 2007 2008 2009 2010 2011 2012

Bila

ngan

pro

duk

/Num

ber

of p

rodu

cts

Tahun / Year

Lulus /Pass

Gagal /Fail

Rajah 3: Jenis-jenis kegagalan ujian makmal bagi produk-produk yang telah diuji pada tahun 2012Figure 3: The types of test failure for products tested in 2012

4

62

16

35

7

2

3

1

2

2

1

0 10 20 30 40 50 60 70

Kandungan bahan aktif / Assay

Kontaminasi Mikrob / Microbial Contaminants

Logam berat / Heavy Metal

Pengesanan campur palsu / Adulteration Screening

Bahan-bahan berkaitan / Related Substances

Keseragaman berat / Uniformity of Weight

pH / pH

Pengisian minima / Minimum Fill

Susut pengeringan / Loss on Drying

Kelembapan air / Moisture Content

Rupabentuk fizikal / Physical Appearance

Bilangan produk / Number of products

Jeni

s ujia

n / T

ype

of Te

stin

g

Nota: Terdapat produk gagal lebih dari satu (1) jenis ujian makmalNote: There were products that failed more than one (1) type of

laboratory test.



Rajah 4: Panggil balik produk atas sebab gagal ujian makmal mengikut kategori bagi tahun 2012Figure 4: Category of products that had been recalled in 2012

0 25

0 03

0 0 20 1

49

0

1114

0

10

20

30

40

50

60

Panggil balik Tahap I / Degree Recall

Panggil balik Tahap II / Degree II Recall

Panggil balik Tahap III / Degree III Recall

Bila

ngan

Pro

duk

/N

umbe

r of

pro

duct

s

Tahap Panggil Balik / Degree of Recall

Preskripsi / Prescription

Bukan Preskripsi / non-prescription

Suplemen Kesihatan / Health Supplement

Semulajadi / Natural

Kosmetik / Cosmetic

Tindakan Punitif

Tindakan susulan kegagalan ujian akan diambil berdasarkan tahap atau risiko kegagalan berkenaan. Arahan panggil balik telah dikeluarkan ke atas produk-produk yang gagal ujian di mana kegagalannya boleh menyebabkan risiko kesihatan terhadap pengguna. Terdapat empat belas (14) produk telah diarahkan panggil balik Tahap II atas kegagalan ujian kritikal dengan risiko kesihatan yang tinggi, manakala 73 arahan panggil balik Tahap III dikeluarkan untuk produk-produk lain yang didapati substandard dengan risiko kesihatan minor. Ini memberikan nilai keseluruhan sebanyak 87 arahan panggilbalik dikeluarkan pada tahun 2012. Kategori produk yang dipanggil balik mengikut tahap panggil balik diperincikan pada Rajah 4.

Selain arahan panggil balik, sebanyak 10 amaran telah dikeluarkan kepada produk-produk yang gagal ujian-ujian lain seperti ujian pengecaian dan ujian keseragaman berat, dan 65 amaran dikeluarkan atas sebab isu berkaitan tatacara ujian yang tidak mematuhi spesifikasi yang ditetapkan.

Bagi tahun 2012, sejumlah lima (5) produk kategori semulajadi dan sembilan (9) kosmetik telah dibatalkan pendaftaran/notifikasi atas sebab keselamatan. Produk-produk yang telah dibatalkan pendaftaran/notifikasi pada tahun 2012 adalah seperti yang disenaraikan dalam Jadual 2.

Punitive Action

Following testing failure, action was taken based on the level and risk of failure. Recall instructions have been issued to products that have failed testing in which the failure may impose health risk to consumers. Fourteen (14) products had been directed to Degree II recall due to failure with high risk, and 73 directive Degree III recalls were issued for other products found substandard with minor health risk. These give a total number of 87 recall instructions issued in year 2012. Category of products that had been recalled in 2012 is detailed in Figure 4.

Apart from recall directives, a total of 10 warnings were issued for products that failed other tests such as disintegration and uniformity of weight, and 65 warnings were given to products related to test procedure found non-compliant with the specification.

In year 2012, a total of five (5) natural products registrations and nine (9) cosmetics notifications had been cancelled due to safety concerns. List of products that have been cancelled in 2012 is as shown in Table 2.


Jadual 2: Senarai Produk Yang Dibatalkan Pendaftaran Pada Tahun 2012Table 2: List of products cancelled in 2012

NAMA PRODUKPRODUCT NAME

NO. PENDAFTARANREGISTRATION NO.

RACUN YANG DIKESANDETECTED POISON

PAO NI KANG MAL20033586T Repaglinide

JT Cordyceps Mycelium MAL09080820T Thiodimetyl-sildenafil (Analog sildenafil).

KAPSUL BENKWAT GINSENG PLUS 500 MG MAL07031076T Yohimbine

Jin Fei Cao San Extract Powder “Sheng Chang” MAL09111756T Ephedrine dan Pseudoephedrine

MYMEN PLUS Capsule 400mg MAL09082840TC Tadalafil

Jadual 3: Senarai Kosmetik Yang Dibatalkan Notifikasi Pada Tahun 2012Table 3: List of cosmetics cancelled in 2012

NAMA PRODUKPRODUCT NAME

NO. NOTIFIKASI (NOT)NOTIFICATION NO.

BAHAN KIMIA YANG DIKESANCHEMICAL DETECTED

Daily Protecting Cream - Joie et Beaute NOT100778850K / NOT100602230K Mercury

La Bliss Skin Brightening Cream NOT100200697K Tretinoin

Sans Dynamic Intensive Light Cream NOT100400422K Mercury

Putih Gebu Sun-Block Collagen Lotion NOT100403485K Mercury

Bio-Clear Intensive Renewal Complex NOT120503338K Tretinoin

MS Wellmood Enhancing Cream NOT100602405K Tretinoin

Renewing Cream NOT100101066K Tretinoin

E Beaute Total Revitalizer Night Cream NOT100601840K Mercury

MS Wellmood Lightening Complex NOT100601840K Mercury

Multi Cream NOT100764415K Tretinoin

Dqistee Night Cream NOT100802185K Mercury

Dqistee Beauty Day Cream NOT100802184K Mercury



Rangkaian Hubungan ASEAN dan Antarabangsa (Kualiti dan Keselamatan)

Seperti mana tahun-tahun sebelumnya, Malaysia meneruskan perkongsian maklumat kualiti dan keselamatan produk-produk kesihatan termasuk kosmetik melalui ASEAN Post Marketing Alert System (PMAS) dan bagi negara luar ASEAN melalui PIC/S Rapid Alert Notification System (RAS). Melalui rangkaian PMAS ini, sebanyak 252 laporan telah diterima dari negara-negara ASEAN manakala Malaysia menyumbang sejumlah 22 (8.73%) laporan.

Menerusi rangkaian perkongsian maklumat RAS pula, sejumlah 381 laporan telah diterima dan tujuh (7) daripadanya telah membawa kepada keputusan panggilbalik secara sukarela oleh pemegang pendaftaran produk.

ASEAN and International Networking On Quality and Safety

As in previous years, Malaysia continues in sharing of information on quality and safety of health products, including cosmetics, through the ASEAN Post Marketing Alert System (PMAS) for ASEAN countries and through the PIC/S Rapid Alert Notification System (RAS) for outside ASEAN countries. Through the PMAS network, a total of 252 reports were received from the ASEAN countries with Malaysia contributing a total of 22 (8.73%) reports.

Through the RAS information sharing network, a total of 381 reports were received and seven (7) of them had led to voluntary recall by the registration holder of the product.



FARMAKOVIGILANSPHARMACOVIGILANCE


Pelaporan Kesan Advers Ubat

Tahun 2012 merupakan tempoh yang mencabar dan memberangsangkan bagi Seksyen Farmakovigilans. Selain memainkan peranan tradisionalnya dalam menilai laporan kesan advers ubat, seksyen ini juga menjalankan pemantauan aktif untuk mengesan isyarat kesan advers ubat yang mungkin menandakan masalah keselamatan ubat, memantau isu-isu keselamatan ubat peringkat tempatan dan antarabangsa, serta melaksanakan strategi pengurangan risiko.

Bilangan laporan kesan advers ubat yang diterima oleh BPFK semakin meningkat sejak tahun 2000. Seperti yang ditunjukkan dalam Rajah 1, sejumlah 10,102 laporan telah diterima pada tahun 2012. Ini menandakan peningkatan sebanyak 7.6% berbanding tahun sebelumnya. Terdapat penurunan sebanyak 40% dalam bilangan laporan Adverse Event Following Immunisation (AEFI) yang diterima. Semua laporan yang telah dibincangkan dan diluluskan semasa mesyuarat Jawatankuasa Penasihat Kesan Advers Ubat Kebangsaan (MADRAC) dihantar ke Pusat Pemantauan WHO- Uppsala (WHO-UMC) untuk dimasukkan ke dalam pangkalan data laporan kesan advers antarabangsa WHO.

Monitoring Product Safety Profile

The year 2012 had been a challenging and rewarding time for the Pharmacovigilance Section. Besides the traditional role of assessing adverse drug reaction (ADR) reports, the section conducted active surveillance to detect ADR signals which may indicate potential drug safety problems, monitored local and international drug safety issues, and implemented risk minimisation strategies.

The number of ADR reports received by the NPCB has been steadily increasing since the year 2000. As shown in Figure 1, a total of 10,102 reports were received in the year 2012. This indicated a 7.6% increase compared to the previous year. There was a 40% decrease in the number of Adverse Event Following Immunisation (AEFI) reports received. The reports which had been presented and approved at the Malaysian Adverse Drug Reaction Advisory Committee (MADRAC) meetings were submitted to the WHO Uppsala Monitoring Centre (WHO-UMC) to be included in the WHO International Database of ADR reports.

FARMAKOVIGILANS PHARMACOVIGILANCE

Rajah 1: Jumlah Laporan Kesan Advers Ubat yang Diterima di Malaysia (2000-2012)Figure 1: Total Number of ADR Reports Received in Malaysia (2000-2012)



Rajah 2: Bilangan Produk yang Disyaki mengikut Kategori Produk (2012)Figure 2: Number of Suspected Products by Product Category (2012)

Laporan kesan advers yang diterima pada tahun 2012 melibatkan sejumlah 11,069 produk yang disyaki, dimana 10,175 (91.9%) adalah produk preskripsi, 663 (6%) produk bukan preskripsi, dan 88 (0.8%) produk-produk lain, iaitu produk tradisional, makanan dan kosmetik. Sejumlah 143 (1.3%) produk tidak berdaftar disyaki menyebabkan kesan advers ubat dalam laporan yang diterima (Rajah 2).

The ADR reports received in 2012 involved a total of 11,069 suspected products, made up of 10,175 (91.9%) prescription products, 663 (6%) non-prescription items, and 88 (0.8%) other products, such as traditional medicines, food and cosmetics. A total of 143 (1.3%) unregistered products were suspected to cause ADRs in the reports received (Figure 2).

Trend pelaporan mengikut kumpulan farmakologi adalah seperti tahun 2011, yang mana vaksin menyumbangkan bilangan laporan kesan advers tertinggi iaitu 1,903 laporan (17%). Ini adalah hasil daripada program pemantauan aktif yang dijalankan terhadap vaksin Human Papilloma Virus (HPV) melalui program immunisasi HPV KKM. Kumpulan vaksin diikuti oleh ubat kardiovaskular dengan 1,778 produk disyaki (16%), dan anti-infektif dengan 1,743 produk disyaki (16%) (Rajah 3).

Following the same trend as 2011, the highest number of ADR reports by pharmacological group was from vaccines (1,903 reports; 17%), followed by cardiovascular drugs with 1,778 suspected products (16%), and anti-infectives with 1,743 suspected products (16%) (Figure 3). The high number of reports involving vaccines is due to the active surveillance program conducted on the Human Papilloma Virus (HPV) vaccine through the Ministry of Health HPV Vaccination Programme.


Rajah 3 : Bilangan Produk yang DIsyaki mengikut Kumpulan Farmakologi (2012)Figure 3: Number of Suspected Products by Pharmacological Group (2012)

Majoriti laporan kesan advers yang diterima melibatkan System Organ Class (SOC) WHO ‘Skin and Appendages Disorders’ (23%), diikuti oleh ‘Body as a whole- General Disorders’ (14%), dan ‘Application Site Disorders’ (14%). Rajah 4 menunjukkan bilangan laporan yang diterima pada tahun 2012 mengikut SOC.

Most of the ADRs reported involved the WHO System Organ Class (SOC) ‘Skin and Appendages Disorders’ (23%), followed by ‘Body as a whole- General Disorders’ (14%), and ‘Application Site Disorders’ (14%). Figure 4 shows a breakdown of all the ADRs reported in 2012 according to SOC.



Rajah 4: Bilangan Kesan Advers Ubat mengikut System Organ Class (2012)Figure 4: Number of Adverse Drugs Reactions by System Organ Class (2012)

Seperti tahun-tahun sebelumnya, majoriti pelapor terdiri daripada pengamal kesihatan profesional Kementerian Kesihatan Malaysia, dengan 5,106 laporan (51%) dikemukakan oleh pegawai farmasi KKM, diikuti oleh 1,636 laporan (16%) oleh jururawat KKM, dan 1,627 (16%) oleh pegawai perubatan KKM (Rajah 5). Hanya 7 laporan (0.07%) diterima daripada pengamal perubatan klinik swasta (GP), 1 laporan (0.01%) daripada ahli farmasi swasta, dan 19 laporan (0.19%) daripada pengguna.

Tahun 2012 menyaksikan penerimaan laporan dari dua kategori pelapor baru, iaitu 2 laporan daripada Rumah Sakit Angkatan Tentera, Taiping, Perak, dan 65 laporan daripada Lembaga Penduduk dan Pembangunan Keluarga Negara (LPPKN) yang mengendalikan Program Immunisasi HPV untuk wanita warganegara Malaysia yang berumur 18 tahun.

Just like previous years, the majority of reporters comprised of Ministry of Health professionals, with 5,106 reports (51%) being submitted by MoH pharmacists, followed by 1,636 (16%) by MoH nurses and 1,627 (16%) by MoH doctors (Figure 5). There were only 7 reports (0.07%) received from private sector general practitioners, 1 report (0.01%) from retail pharmacists, and 19 reports (0.19%) from consumers.

In 2012, there were submission of reports from two new categories, namely 2 reports from the Armed Forces Hospital in Taiping, Perak, and 65 reports from the National Population and Family Development Board (LPPKN) which conducts the HPV Vaccination Program for 18 year-old Malaysian women.


Cadangan WHO untuk Pusat Farmakovigilans Kebangsaan yang optimum termasuk penyerahan lebih daripada 200 laporan untuk setiap juta penduduk, yang menetapkan sasaran kira-kira 6,000 laporan untuk populasi Malaysia sebanyak 28.9 juta penduduk. Walaupun sasaran ini telahpun diatasi sebanyak 68%, masih terdapat kekurangan dari segi pelaporan kesan advers ubat, terutamanya di kalangan pengamal perubatan sektor swasta.

Antara langkah-langkah yang diambil untuk menggalakkan pelaporan kesan advers ubat, terutamanya oleh pengamal perubatan sektor swasta, adalah perkembangan sistem pelaporan atas-talian yang efisien dan mempromosikan pelaporan kesan advers oleh ahli farmasi komuniti melalui buletin Persatuan Farmasi Malaysia (MPS).

The WHO recommendations for an optimal National Pharmacovigilance Centre include the submission of more than 200 reports per million population per year, which sets a target of about 6,000 reports for Malaysia’s population of 28.9 million. Although this target has been exceeded by 68%, ADRs are still under reported especially among private healthcare professionals.

Among the initiatives being taken to further increase the reporting of ADRs, especially by private healthcare professionals, are the development of an efficient online-reporting system and promoting ADR reporting by community pharmacists through the Malaysian Pharmaceutical Society (MPS) bulletin.

Rajah 5: Bilangan Laporan Kesan Advers mengikut Kategori Pelapor (2008-2012)Figure 5: Number of ADR Reports by Category of Reporter (2008-2012)



Laporan Suspected Unexpected Serious Adverse Reaction (SUSAR)

Sebanyak 3,742 laporan SUSAR telah diterima oleh BPFK pada tahun 2012. Laporan-laporan ini merangkumi kesemua kajian klinikal yang dijalankan di Malaysia dan memerlukan CTIL dan CTX. Sumber laporan-laporan ini adalah daripada tapak Malaysia atau tapak antarabangsa dalam suatu kajian klinikal multinational. Masa yang diambil dalam melaporkan SUSAR ini adalah sentiasa dipantau oleh NPCB mengikut prinsip-prinsip dalam GCP.

Menggalakkan Pelaporan Kesan Advers Ubat

Sepanjang tahun 2012, pelbagai program latihan telah diadakan dengan tujuan meningkatkan kualiti laporan kesan advers dan kesedaran mengenai kepentingan melapor. Jadual 1 menyenaraikan program-program yang telah dianjurkan serta ceramah yang disampaikan oleh Seksyen Farmakovigilans, BPFK:

Suspected Unexpected Serious AdverseReaction (SUSAR) Report

A total of 3,742 SUSAR reports were received by NPCB in 2012. The SUSAR reports were from the clinical trials conducted in Malaysia requiring CTIL and CTX. The sources of these SUSAR were from either local Malaysia sites or other international sites in the multinational clinical trials. The timeframe of these SUSAR reporting was monitored by NPCB in accordance to the Principles of GCP.

Promoting ADR Reporting

Throughout the year 2012, various training programmes were held with the aim of improving the quality of ADR reporting and increasing awareness on the importance of reporting. Table 1 lists the programmes conducted or presentations delivered by the Pharmacovigilance Section of NPCB:

Jadual 1: Program Latihan atau Ceramah oleh Seksyen Farmakovigilans, BPFK pada tahun 2012Table 1: Programmes or Presentations by the Pharmacovigilance Section, NPCB in 2012

Bil.No.

TarikhDate

Program/ Topik CeramahProgramme / Presentation Topic

PenganjurOrganiser

1 April 2012 Bengkel Pengurusan Program Vaksinasi Human Papilloma Virus (HPV)Workshop on the Management of Human Papilloma Virus (HPV) Vaccination Programme

Lembaga Penduduk dan Pembangunan Keluarga Negara (LPPKN)National Population and Family Development Board

2 April 2012 Kursus Keselamatan Ubat: Apa itu ADR?Medication Safety Course: What is an ADR?

Hospital KajangKajang Hospital

3 April 2012 Taklimat Pelaporan Kesan Advers UbatBriefing on Adverse Drug Reaction Reporting

Jabatan Kesihatan Negeri PerakPerak State Health Department

4 April 2012 Bengkel Pengurusan AEFIWorkshop on the Management of Adverse Events Following Immunization (AEFI)

Bahagian Perkhidmatan Farmasi KKM Pharmaceutical Services Division MOH

5 April 2012 Asia-Pacific Economic Cooperation And Standards: Product Complaints and Pharmacovigilance

Asia-Pacific Economic Cooperation

6 May 2012 Bengkel ADR: Laporan Terkini MADRACADR Workshop: MADRAC Updates

Hospital SelayangSelayang Hospital

7 May 2012 45th MPS Annual Seminar Focus on Non-Communicable Diseases: Awareness and Importance of ADR Reporting

Malaysian Pharmaceutical Society

8 May 2012 Bengkel Causality Assessment dan Pelaporan ADR BerkualitiCausality Assessment and Quality Reporting for ADR Workshop

Seksyen Farmakovigilans, BPFKPharmacovigilance Section, NPCB


Bil.No.

TarikhDate

Program/ Topik CeramahProgramme / Presentation Topic

PenganjurOrganiser

9 June 2012 7th National Pharmacy R&D Conference 2012: The Future of Pharmacovigilance

Bahagian Perkhidmatan Farmasi KKM and Malaysian Pharmaceutical Society

10 June 2012 Bengkel Pelaporan Kesan Advers Ubat berkualiti: Causality Assessment Kesan Advers UbatQuality Reporting for ADR Workshop: Causality Assessment Of ADRs

Seksyen Farmakovigilans, BPFKPharmacovigilance Section, NPCB

11 June 2012 Ceramah Kursus Farmasi: Kesan Advers UbatPharmacy Course Lecture: Adverse Drug Reactions

Faculty of Pharmacy, Cyberjaya University College of Medical Sciences

12 June 2012 Sesi Pendidikan Kesihatan Berterusan (CME): Kesan Advers UbatContinuous Medical Education Session: Adverse Drug Reactions

Institut Jantung Negara (IJN)National Heart Institute (IJN)

13 June 2012 Bengkel Dokumentasi Farmasi Wad: Pelaporan Kesan Advers UbatWard Pharmacy Documentation Workshop: ADR Reporting

Jabatan Kesihatan Negeri SelangorSelangor State Health Department

14 July 2012 Bengkel Pengurusan Program Vaksinasi Human Papilloma Virus (HPV)Workshop on the Management of Human Papilloma Virus (HPV) Vaccination Programme

Lembaga Penduduk dan Pembangunan Keluarga Negara (LPPKN)National Population and Family Development Board

15 September 2012

Sesi Pendidikan Kesihatan Berterusan (CME): Pelaporan Berkualiti dan Causality Assessment Kesan Advers UbatContinuous Medical Education Session: Quality Reporting & Causality Assessment Of ADRs

Hospital Sg. BulohSg. Buloh Hospital

16 September 2012

Kursus Keselamatan Ubat: Pelaporan Kesan Advers Ubat BerkualitiMedication Safety Course: Quality Reporting of ADRs

Unit Farmasi, Hospital Orang Asli Gombak, SelangorPharmacy Unit, Gombak Orang Asli Hospital, Selangor

17 October 2012

Bengkel Keselamatan Ubat untuk Pegawai Farmasi dan Penolong Pegawai FarmasiWorkshop on Medication Safety for Pharmacists and Assistant Pharmacists

Jabatan Kesihatan Negeri SembilanNegeri Sembilan State Health Department

18 October 2012

Taklimat Farmakovigilans & Pelaporan Kesan Advers UbatBriefing on Pharmacovigilance & Adverse Drug Reaction Reporting

Jabatan Kesihatan Negeri MelakaMelaka State Health Department

19 December 2012

Kursus Keselamatan Ubat: Pelaporan Kesan Advers Ubat BerkualitiMedication Safety Course: Quality Reporting of ADRs

Unit Farmasi, Hospital Orang Asli Gombak, SelangorPharmacy Unit, Gombak Orang Asli Hospital, Selangor

20 December 2012

Sesi Pendidikan Kesihatan Berterusan (CME): Farmakovigilans di Malaysia Continuous Medical Education Session: Pharmacovigilance in Malaysia

Hospital Tengku Ampuan Rahimah, KlangTengku Ampuan Rahimah Hospital, Klang



Produk Campur Palsu

Seksyen Farmakovigilans juga menerima laporan kesan advers ubat yang beserta sampel produk, biasanya untuk produk-produk tradisional, makanan dan kosmetik, yang dihantar oleh pengguna atau pengamal perubatan yang mengesyaki produk dicampur palsu. BPFK menjalankan ujian makmal ke atas sampel-sampel ini bagi mengenal pasti bahan terlarang yang disyaki, termasuk steroid, hormon seks, antihistamin, ubat antiradang bukan steroid (NSAID), atau agen pelangsing.

Antara laporan kesan advers yang dibentangkan semasa mesyuarat-mesyuarat MADRAC tahun 2012, sejumlah 26 sampel produk telah dihantar untuk ujian makmal dan 12 (46%) didapati mengandungi bahan terlarang. Kesemua produk campur palsu ini terdiri daripada produk tradisional yang tidak berdaftar. Penemuan ini dimaklumkan kepada Bahagian Penguatkuasaan Farmasi untuk tindakan lanjut. Jadual 2 menunjukkan senarai produk dan bahan terlarang yang dikesan.

Adulterated Products

The Pharmacovigilance Section receives ADR reports with samples of products, mainly for traditional medicines, food and cosmetics, sent in by consumers or healthcare professionals who suspect adulteration. The NPCB conducts tests on these samples to identify suspected adulterants including steroids, sex hormones, antihistamines, NSAIDs, or slimming agents.

Among the ADR reports presented at MADRAC meetings in 2012, a total of 26 products were sent for laboratory testing and 12 (46%) were found to be adulterated. These were all unregistered traditional products, therefore information on the adulterants detected was conveyed to the Pharmacy Enforcement Division for further action. Table 2 shows the list of products and adulterants detected.

Jadual 2: Bahan Terlarang yang Dikesan dalam Sampel Produk Tradisional Tidak BerdaftarTable 2: Adulterants Detected in Samples of Unregistered Traditional Products

No. Nama ProdukProduct Name

Kesan Advers yang DilaporkanAdverse Reactions Reported

Bahan Terlarang yang DikesanAdulterants Detected

1 Ubat Gout Cushing’s Syndrome Phenylbutazone, paracetamol2 Black pill Cortisol decreased Dexamethasone

3 Majun Dua IstimewaIncreased appetitie, acute renal failure, abdominal distension, weight increase and black stool

Dexamethasone

4 Pill Pembersih Darah Cushing’s Syndrome Chlorpheniramine, ibuprofen

5 Twin Bee Wang Ling Dan Water retention, face oedema, weight increase Dexamethasone, chlorpheniramine

6 ABC Acai Berry Herba Pelangsing Weight decrease Sibutramine

7 Maajun Burung Unta Hyperglycaemia, Cushing’s Syndrome Dexamethasone

8 Lami Palpitation, breath shortness, chest pain Sibutramine

9 Edoly Capsule Acute hepatitis Chlorpheniramine

10Xue Yagaozhang Feng Qing Cao Yao Cao Huang Nu Mu Sinide Jin Xing

Diabetes mellitus, Cushing’s Syndrome Dexamethasone

11 Maajun Kuat Khasiat Sakit Pinggang Stevens Johnson Syndrome Dexamethasone

12 Ubat Penguat Syaraf Pruritus, maculopapular rash Dexamethasone, prednisolone


Komunikasi Risiko dan Penyebaran Maklumat Keselamatan Seksyen Farmakovigilans mengeluarkan tiga terbitan Buletin MADRAC pada tahun 2012, serta satu terbitan surat berita REAKSI setiap 2 bulan. Terbitan-terbitan ini mengandungi maklumat terkini mengenai isu-isu keselamatan ubat dan menyerlahkan keputusan penting yang dibuat semasa mesyuarat MADRAC terutamanya keputusan yang melibatkan pertukaran amalan mempreskrib ubat.

Komunikasi risiko telah dijalankan pada tahun 2012 menerusi sejumlah sepuluh (10) kenyataan akhbar, lapan (8) surat Dear Healthcare Professional Communication (DHPC), serta surat amaran atau edaran produk, dan maklumbalas kepada pelapor.

Keselamatan Ubat: Pemantauan dan Tindakan Pengurangan Risiko

Selaras dengan pergerakan terhadap pemantauan aktif dan pengesanan isyarat, isu-isu keselamatan ubat tempatan dan antarabangsa dikenalpasti dan dipantau oleh Unit Kemaskini Keselamatan. Isu-isu keselamatan yang melibatkan produk berdaftar di Malaysia dibentang dan dibincangkan semasa mesyuarat MADRAC, dan tindakan pengurangan risiko akan diambil. Sejumlah 12 laporan ringkas berkaitan isu keselamatan ubat telah dibentangkan kepada MADRAC pada tahun 2012 (seperti tersenarai di Jadual 3).

Risk Communication and Dissemination of Safety InformationThe Pharmacovigilance Section published three issues of the MADRAC Bulletin in 2012, besides issuing the REAKSI newsletter every two months. These publications contain updates on the latest drug safety issues and highlight important decisions made at MADRAC meetings especially those involving changes to prescribing practices.

Risk communication was carried out in 2012 through a total of ten (10) media statements, eight (8) Dear Healthcare Professional Communication (DHPC) letters, as well as via product alerts or circulars, and feedback to reporters.

Drug Safety: Monitoring and Risk Minimisation Action

In-line with the shift towards active surveillance and signal detection, drug safety issues both locally and internationally are identified and monitored by the Safety Updates Unit. Safety issues involving products registered in Malaysia are presented and discussed at the MADRAC meetings, and risk minimisation action is taken. A total of 12 summary reports on drug safety issues were presented to MADRAC in 2012 (as listed in Table 3).



Jadual 3: Laporan Ringkas yang Disampaikan Semasa Mesyuarat MADRAC Tahun 2012 dan Tindakan yang TerhasilTable 3: Summary Reports Presented at MADRAC meetings in 2012 and Resulting Action

TarikhDate

Isu Keselamatan yang DibincangkanTopic of Safety Issue Discussed

Keputusan MADRAC/ Tindakan yang TerhasilMADRAC Decision/ Resulting Action

16/2/2012 Rasilez® (Aliskiren): Termination Of ALTITUDE Study In High Risk Patients With Diabetes And Renal Impairment

Maklumat ini diterbitkan dalam Buletin MADRAC untuk makluman pengamal perubatan.This information was communicated to healthcare professionals via the MADRAC Bulletin.

12/4/2012 Strontium Ranelate: New Contraindications In VTE & Revised Warnings On Severe Skin Reactions

Sisip bungkusan dikemaskini dengan maklumat kontraindikasi ini, dan pemantauan rapi diteruskan oleh BPFK untuk mendapat maklumat lanjut berkenaan isu ini.Update of package insert to include these contraindications, and close monitoring by NPCB to obtain further information on this issue.

Simvastatin: New Restrictions To Reduce Risk Of Muscle Injury

Sisip bungkusan dikemaskini dengan maklumat baru berkenaan had dos dan kontraindikasi.Update of package insert to include new dose limitations and contraindications.

Clostridium difficile- associated Diarrhoea Can Be Associated With Proton Pump Inhibitors(PPIs)

Maklumat keselamatan ini diterbitkan dalam surat berita Reaksi untuk menggalakkan penilaian semula penggunaan PPI untuk tempoh berpanjangan. This safety information was published in the REAKSI newsletter to encourage review of the long-term use of PPIs.

Association of Domperidone Maleate With Serious Ventricular Arrhythmias and Sudden Cardiac Death

Pemantauan berterusan profil keselamatan produk ini oleh BPFK.Continued monitoring of the drug safety profile by NPCB.

24/5/2012 COX-2 Inhibitors: Appeal On Statement Regarding Limitation Of Use As Second-Line Therapy

Rayuan untuk mengeluarkan kenyataan ini dari sisip bungkusan telah dipertimbangkan.

The appeal to remove this statement from the package insert was accepted.

Celexa® (Citalopram Hydrobromide): Drug Safety Communication: Abnormal Heart Rhythms Associated With High Doses

Maklumat ini dimasukkan dalam sisip bungkusan semua produk tempatan supaya mengikut produk innovator.

This information was included in package inserts for all local products in line with the innovator product.

21/7/2012 Primperan® (Metoclopramide): The French Agency For The Safety Of Healthcare Products (AFSSAPS)’s Regulatory Action To Contraindicate In Paediatric Patients Aged Less Than 18 Years

Maklumat kontraindikasi ini dimasukkan dalam sisip bungkusan Primperan®.

Information on the contraindication is included in the package insert for Primperan®.


TarikhDate

Isu Keselamatan yang DibincangkanTopic of Safety Issue Discussed

Keputusan MADRAC/ Tindakan yang TerhasilMADRAC Decision/ Resulting Action

20/9/2012 Reduction Of Maximum Dose From 32mg To 16 Mg With Ondansetron (Zofran®) Intravenous Due To QT Prolongation

Amaran tambahan dan maklumat keselamatan dimasukkan dalam sisip bungkusan.Inclusion of additional warnings and safety information in package insert.

Contraindication Of Volibris® (Ambrisentan) In Patients With Idiopathic Pulmonary Fibrosis (IPF)

Kemaskini sisip bungkusan dengan maklumat kontraindikasi baru ini. Update of package insert with the new contraindication.

6/12/2012 Issue: Appeal On Re-Registration Of Nimesulide Tablet

Rayuan tidak dipertimbangkan disebabkan risiko penggunaan nimesulide dinilai melebihi kebaikannya. Appeal was not considered as the risk of using nimesulide outweighs the benefits.

Class Labeling Of Statins Kemaskini sisip bungkusan dengan maklumat kesan advers kognitif serta peningkatan bacaan HbA1c dan paras gula darah dalam keadaan berpuasa.Update of package inserts to include information on cognitive adverse events, and increased HbA1c and fasting blood glucose.

Salah satu contoh tindakan pengurangan risiko yang dijalankan oleh Seksyen Farmakovigilans yang menampakkan hasil menggalakkan melibatkan ubat allopurinol. Pada tahun 2007, MADRAC telah membincangkan isu bilangan laporan kesan advers allopurinol yang semakin meningkat, terutamanya kes kesan advers kulit yang serius apabila allopurinol digunakan di luar indikasi yang diluluskan. Tindakan awal yang diambil termasuk mengingatkan preskriber dan menerbitkan artikel berkaitan penggunaan allopurinol secara betul.

Namun demikian, BPFK terus menerima laporan kesan advers allopurinol yang dipreskrib untuk ‘asymptomatic hyperuricaemia’. Tindakan lanjut dilaksanakan pada tahun 2011 dan 2012, iaitu mengetatkan kategori mempreskrib allopurinol di fasiliti KKM kepada doktor pakar, dan pengeluaran ujian asid urik daripada analisis profil buah pinggang yang rutin. Surat peringatan juga dihantar kepada doktor yang didapati mempreskrib allopurinol di luar indikasi yang diluluskan.

Jumlah laporan kesan advers allopurinol menurun dari 114 pada tahun 2011, kepada 104 pada 2012. Bilangan laporan kesan advers yang melibatkan penggunaan allopurinol untuk ‘asymptomatic hyperuricaemia’ juga

One example of risk minimisation action initiated by the Pharmacovigilance Section which showed promising results involves allopurinol. In 2007, MADRAC discussed the issue of increasing number of allopurinol ADR reports, especially involving serious skin reactions when allopurinol is used outside the approved indication. Initial action taken involved issuing reminders to prescribers and publishing articles regarding the appropriate use of allopurinol.

In spite of these actions, the NPCB continued to receive ADR reports of allopurinol prescribed for asymptomatic hyperuricaemia. Additional measures were implemented in 2011 and 2012, such as to restrict the prescribing category of allopurinol in MOH facilities to specialists, and removal of uric acid testing from the routine renal profile analysis. Reminder letters are also sent out to prescribers found to use allopurinol outside the approved indications.

The total number of allopurinol ADR reports decreased from 114 in the year 2011, to 104 in 2012. The number of ADR cases involving use of allopurinol for asymptomatic hyperuricaemia also decreased from 13 to 8 cases, and



menurun daripada 13 kepada 8 kes, dan penggunaan tablet allopurinol di fasiliti KKM menurun sebanyak 23% dalam tempoh setahun ini. BPFK akan terus memantau isu ini dengan rapi untuk mengawal penggunaan allopurinol yang tidak sesuai dalam usaha mengurangkan dan mengelakkan kesan advers disebabkan ubat ini.

Pemantauan Keselamatan Ubat Selepas Pemasaran untuk Entiti Kimia Baru (NCE) – Periodic Safety Update Reports (PSUR)

Unit Kemaskini Keselamatan juga mengendalikan penilaian Periodic Safety Updates Reports (PSUR) yang diterima dari pengeluar. PSUR adalah wajib dikemukakan untuk Entiti Kimia Baru (NCE) dan produk biologi baru selama 5 tahun selepas pendaftaran. PSUR mengandungi maklumat berkenaan profil keselamatan produk di negara-negara dimana ia didaftarkan, dan sebarang perubahan dalam maklumat keselamatan produk. Pada tahun 2012, sejumlah 181 PSUR telah dinilai, seterusnya melibatkan kemaskini maklumat keselamatan dalam sisip bungkusan 88 produk.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Sejak April 2011, pengemukaan Risalah Maklumat Ubat untuk Pengguna (RiMUP) telah diwajibkan untuk produk yang boleh diadministrasi sendiri oleh pengguna. Pada tahun 2012, 1347 RiMUP untuk produk berdaftar telah dikemukakan oleh pemegang pendaftaran produk. Namun, hanya 468 (35%) telah diluluskan dan dimuat naik pada laman web BPFK untuk kegunaan pengguna atau pengamal kesihatan professional. Baki RiMUP yang dikemukakan masih di bawah penilaian.

the total usage of allopurinol tablets at Ministry of Health facilities dropped by 23% in this time period. The NPCB will continue to monitor this issue closely in the bid to reduce and prevent allopurinol-related ADRs due to inappropriate use.

Post-Market Drug Safety Monitoring for New Chemical Entities- Periodic Safety Update Reports (PSUR)

The Safety Updates Unit also handles assessment of Periodic Safety Update Reports (PSURs) received from manufacturers. The submission of PSURs is compulsory for New Chemical Entities and new biological products for 5 years post-registration. PSURs contain information on the product safety profile in registered countries, and any changes in product safety information. In 2012, a total of 181 PSURs were assessed, resulting in implementation of package insert changes for 88 products to ensure that they contain the latest safety information.

Consumer Medication Information Leaflets (RiMUP)

Since April 2011, the submission of Consumer Medication Information Leaflets (or Risalah Maklumat Ubat untuk Pengguna- RiMUP) was made compulsory for products which are self-administered by consumers. In the year 2012, 1347 RiMUPs of registered products were submitted by the product registration holders. However, only 468 (35%) were approved and uploaded on the NPCB website to be downloaded by consumers or healthcare professionals. The remaining RiMUPs are still under evaluation.



KOSMETIKCOSMETICS


KOSMETIK COSMETICS

Produk kosmetik adalah dikawal di bawah Peraturan Kawalan Dadah dan Kosmetik 1984.

Semua produk kosmetik yang akan dipasarkan di Malaysia perlu melalui prosedur notifikasi, di mana syarikat pemegang notifikasi perlu mengemukakan notifikasi kepada Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) sebelum produk kosmetik boleh dikilang, diimport, diedarkan atau dijual. Pemegang notifikasi adalah bertanggungjawab sepenuhnya untuk memastikan keselamatan, kualiti serta tuntutan produk yang dinyatakan pada label dan iklan dapat disokong dengan bukti dokumentasi yang mencukupi bagi menjamin kepentingan pengguna dari pengilang dan pemegang notifikasi yang tidak bertanggungjawab.

Produk-produk kosmetik bernotifikasi dipantau secara sistematik dan aktif menerusi Program Pengawasan Mutu Produk Kosmetik Bernotifikasi di Pasaran bagi memastikan produk kosmetik di pasaran adalah berkualiti dan selamat kepada pengguna.

Beberapa kriteria telah ditetapkan bagi mengenalpasti produk-produk untuk program ini antaranya produk berisiko tinggi seperti produk pemutih kulit dan produk bayi, produk yang berpotensi membuat tuntutan yang melampaui skop takrifan kosmetik, produk dengan nama yang mengelirukan dan lain-lain.

Aktiviti-aktiviti yang dijalankan di bawah di Program Pengawasan Mutu Produk Kosmetik Bernotifikasi di pasaran antaranya:

i. Penyaringan maklumat & formulasi produk kosmetikii. Audit ke atas Fail Maklumat Produkiii. Pensampelan & pengujian kualiti produk iv. Semakan label & tuntutan produk v. Audit pengilang kosmetik vi. Pengendalian aduan pengguna/orang ramai/agensi

kerajaanvii. Pemantauan iklan kosmetik viii. Pemonitoran kesan advers akibat penggunaan

produk kosmetikix. Perkongsian maklumat keselamatan produk

kosmetik di kalangan negara ASEAN melalui ASEAN Post Market Alert

Produk-produk kosmetik yang gagal mematuhi keperluan undang-undang yang ditetapkan di dalam Guidelines for Control of Cosmetic Products in Malaysia akan dikenakan tindakan punitif seperti pembatalan notifikasi oleh Pengarah Kanan Perkhidmatan Farmasi (PKPF).

Cosmetic products are regulated under the Control of Cosmetic and Drug Regulation 1984.

All cosmetic products to be sold in Malaysia need to undergo a notification procedure; the notification holders need to submit notification to the National Pharmaceutical Control Bureau prior to manufacturing, importation, distribution or retailing the products. Notification holders are fully responsible to ensure product safety, quality and claim benefits printed on the label. They also need to ensure that advertisement claims are sufficiently supported. The NPCB takes this responsibility to ensure that consumers are safeguarded against irresponsible manufacturers and importers.

Notified cosmetics are monitored systematically and actively through the Post Market Surveillance for Notified Cosmetics Program. This ensures that notified cosmetic products in the market are of acceptable quality and safe to use.

Several criteria have been set to identify products to be sampled under this program. They include high risk products such as skin whitening preparations, baby products, products that are potentially over claimed, and products with misleading names etc.

Post Market Surveillance activities that are conducted for notified cosmetics include:

i. Screening of product information and formulation.ii. Product Information File audit.iii. Product sampling and quality testing.iv. Label and product claim monitoring.v. Cosmetic Manufacturer audit.vi. Handling of complaints by consumers, public and

government agencies.vii. Monitoring of cosmetic advertisements.viii. Monitoring of adverse events following the use of

cosmetic products.ix. Cosmetic product information sharing among ASEAN

member countries through ASEAN Post Market Alert.

Punitive actions such as notification to cancel by the Director of Pharmaceutical Services (DPS) are taken towards cosmetic product owners that fail to meet the stipulated regulations and requirements set in the Guidelines for Control of Cosmetic Products in Malaysia.



Penerimaan Notifikasi Kosmetik

Pada tahun 2012, sejumlah 66,913 produk kosmetik telah dinotifikasikan dengan pihak Biro Pengawalan Farmaseutikal Kebangsaan (BPFK), Kementerian Kesihatan Malaysia (KKM). Terdapat penurunan dalam bilangan notifikasi produk yang diterima berbanding tahun sebelumnya kerana jumlah ini adalah bergantung kepada bilangan permohonan yang dikemukakan oleh pihak syarikat (Rajah 1).

Cosmetic Notification

In 2012, a total of 66,913 cosmetics have been notified with the National Pharmaceutical Control Bureau (NPCB) , Ministy of Health (MOH). There is a slight decrease in the number of cosmetic notification received as compared with the previous year, however the figure would depend entirely on notification holders submissions. (Figure 1).

Rajah 1: Bilangan Produk Kosmetik yang Bernotifikasi (2008-2012)Figure 1: Number of Notified Cosmetic Products (2008-2012)

0

10000

20000

30000

40000

50000

60000

70000

2008 2009 2010 2011 2012

3053137466

5326269747

66913

CosmeticNotification/NotifikasiKosmetik

Penolakan Permohonan Notifikasi

Semua permohonan notifikasi yang diterima akan melalui proses penyaringan awal secara automatik melalui sistem Quest. Bagi produk yang memerlukan semakan lanjut, semakan akan dijalankan secara manual oleh pegawai penilai. Permohonan notifikasi akan ditolak sekiranya produk tersebut didapati mengandungi bahan terlarang atau bahan melebihi had dan syarat yang dibenarkan.

Pada tahun 2012, sebanyak 1,052 permohonan notifikasi kosmetik telah ditolak kerana tidak mematuhi keperluan yang ditetapkan (Rajah 2). Sejumlah 1,015 (96.5%) permohonan telah ditolak kerana formulasi produk didapati mengandungi bahan terlarang atau bahan yang melebihi had dan syarat yang dibenarkan. Manakala 37 (3.5%) permohonan lagi adalah terdiri daripada produk-produk yang tidak dikelaskan sebagai kosmetik, antaranya produk yang digunakan untuk rawatan perubatan, produk pelangsingan dan produk untuk rangsangan seksual.

Rejection of Notification Application

All notification submissions received are automatically screened via the Quest system. Some products that require further evaluation are checked manually by evaluating officers. Notification applications that contain banned ingredients or ingredients that have exceeded the permissible limit and condition of use will be rejected.

In 2012, a total of 1,052 notification applications were rejected because they failed to fulfill notification requirements (Figure 2). A total of 1,015 (96.5%) applications were rejected because the product formulation contained banned ingredients and/or ingredients that have exceeded the permissible levels or condition of use while the remaining 37 (3.5%) were products that were not categorized as cosmetics. These include products intended for medicinal use, slimming/weight loss preparations and sex stimulants.


The NPCB’s strict implementation of notification application rejection at the point of notification effectively ensures that non-compliant products are prevented from entering the Malaysian consumer market.

Notification Cancellation

Notified cosmetics are actively monitored to ensure that they comply with the regulations. A total number of 397 cosmetic notifications were found to be non-compliant and were cancelled in 2012 (Figure 3).

Starting from 2012, there was a change in the statistical reporting format for notification cancellation whereby notification applications that were rejected was reported separately as in Figure 2.

Penolakan permohonan notifikasi kosmetik memastikan bahawa produk-produk kosmetik yang tidak menepati garispanduan dihalang daripada memasuki pasaran Malaysia.

Pembatalan Notifikasi Kosmetik

BPFK sentiasa memantau produk-produk kosmetik bernotifikasi dipasaran bagi memastikan produk-produk tersebut sentiasa mematuhi keperluan undang-undang yang ditetapkan. Sebanyak 397 notifikasi kosmetik telah dibatalkan pada tahun 2012 (Rajah 3).

Mulai tahun 2012, terdapat perubahan pada format pelaporan statistik bagi produk-produk kosmetik yang dibatalkan dimana permohonan notifikasi yang ditolak dinyatakan secara berasingan seperti pada Rajah 2.

Rajah 2: Penolakan Permohonan Notifikasi Produk Kosmetik bagi Tahun 2012Figure 2: Rejection of Cosmetic Notification Application in 2012

1015(95.5%)

373.5%

Formulasi

Bukan Kosmetik

Rajah 3 : Bilangan Pembatalan Notifikasi Produk Kosmetik (2008-2012)Figure 3: Number of Notification Cancellation (2008-2012)

328 293

1076

2359

397

0

500

1000

1500

2000

2500

2008 2009 2010 2011 2012



Pecahan untuk sebab-sebab pembatalan notifikasi pada tahun 2012 (Rajah 4) adalah seperti berikut : 155 (39.04%) notifikasi dibatalkan kerana formulasi produk tidak menepati garispanduan yang ditetapkan, 86 (21.66%) notifikasi dibatalkan kerana nama dan tuntutan produk melampaui skop takrifan kosmetik, 72 (18.14%) notifikasi kosmetik dibatalkan susulan daripada aktiviti surveilans seperti semakan label, iklan kosmetik dan kegagalan ujian kualiti, 57 (14.63%) pembatalan notifikasi dikeluarkan kerana pengilang gagal mematuhi Amalan Pengilangan Baik (APB), 20 (5.04%) notifikasi dibatalkan kerana syarikat gagal mengemukakan surat perlantikan kuasa yang sah dari pemilik produk dan 7 (1.76%) produk dibatalkan atas permintaan syarikat. Tren penurunan bilangan pembatalan merupakan indikasi positif bahawa pihak pemegang notifikasi semakin arif dengan garispanduan dan keperluan notifikasi kosmetik. BPFK berharap agar bilangan pembatalan yang disebabkan oleh kekurangan pengetahuan dan pemahaman terhadap garispanduan dan keperluan notifikasi dapat dikurangkan ke tahap minima.

The breakdown for the total cancellation of notified cosmetics carried out in 2012 (Figure 4) are as follows: 155 (39.04%) notifications were cancelled because product formulations were not compliant to stipulated guidelines, 86 (21.66%) were contributed by product name/claim that were found to be beyond the cosmetic scope of use, 72 (18.14%) cosmetic notification cancellations were detected through post market surveillance activities such as screening of cosmetic advertisements, label monitoring and failure to conform to quality testing, 57 (14.36%) cancellations were issued due to manufacturer’s failure to comply with the Good Manufacturing Practice (GMP), 20 (5.04%) notifications were from companies that were unable to obtain valid letters of authorization for notification and 7 (1.76%) products were cancelled following a company’s request to do so. The downward trend is a positive indication that cosmetic companies are getting better versed and more familiar with the cosmetic guidelines and requirements. The ultimate aim of the NPCB is to reduce drastically the number of cancellations due to poor understanding of guidelines.

Rajah 4 : Sebab Pembatalan Notifikasi Produk Kosmetik bagi Tahun 2012Figure 4: Reasons for Cosmetic Notification Cancellation in Year 2012

155 (39.04%)

86 (21.66%)

20 (5.04%)

72 (18.14%)

57 (14.36%)7 (1.76%)

Formulation Screening

Not Cosmetics

No Valid LOA/ Termination ofcompanyFrom Surveillance Activities

GMP Issues


Pengendalian Audit Fail Maklumat Produk

Pengendalian audit Fail Maklumat Produk dijalankan bagi memastikan bahawa pemegang notifikasi menyimpan semua maklumat berkenaan data keselamatan untuk semua produk kosmetik yang dinotifikasikan oleh mereka dan tuntutan produk dapat disokong dengan dokumen yang mencukupi.

Audit Fail Maklumat Produk dilaksanakan terhadap produk kosmetik berdasarkan kepada kriteria tertentu antaranya produk pemutih kulit, produk berisiko tinggi seperti produk untuk kegunaan sekitar mata dan produk kegunaan bayi, produk dari pengilang atau syarikat yang mempunyai sejarah seperti panggilbalik produk, aduan produk, gagal ujian kualiti, pengilang yang mempunyai status APB yang lemah serta lain-lain yang dikenalpasti semasa proses penyaringan maklumat produk seperti produk dengan nama dan tuntutan yang mengelirukan yang berpotensi untuk membuat tuntutan melampaui skop takrifan kosmetik atau produk yang disyorkan untuk tujuan rawatan seperti mesoterapi dan minyak urut.

Sejumlah 335 fail maklumat produk telah diaudit pada tahun 2012 (Rajah 5). Melalui sesi-sesi audit yang dijalankan, didapati masih terdapat kekangan dari segi pemahaman dalam keperluan Fail Maklumat Produk terutamanya di kalangan industri kecil sederhana. Kebanyakkan fail maklumat produk didapati kurang memuaskan.

Product Information File (PIF) Audit

Product Information File (PIF) audits are carried out to ensure that notification holders have fulfilled their responsibility to keep PIFs. These contain important information with regards to the product safety of their notified products as well as supporting documents for the claimed benefits of the cosmetic product.

The PIF audits are conducted on products with selected criteria such as skin whitening products, high risk products such as products applied near the eye areas and baby products. Manufacturers or companies with history of product recall, product complaint, products that fail laboratory testing and manufacturers with poor GMP and other additional criteria such as products with misleading names, product with claims that are beyond cosmetic scope or possibly intended for treatment purposes such as mesotherapy, massage oil with therapeutic indication, and slimming products.

A total of 335 PIFs were audited in year 2012 (Figure 5). Through the audits, it was observed that there is an obvious lack of understanding of the PIF requirements amongst the cosmetic industry. Local companies especially small medium enterprises (SMEs) struggled to understand and comply with the PIF requirements and many PIFs were found to be unsatisfactory.

Rajah 5: Bilangan Fail Maklumat Produk yang Diaudit (2008-2012)Figure 5: Number of Product Information Files (PIF) audited (2008-2012)

12

285

377

664

335

0

100

200

300

400

500

600

700

2008 2009 2010 2011 2012

Product InformationFile (PIF) Audit /Audit Fail MaklumatProduk (PIF)



Responding to these findings, the NPCB has taken the initiative to improve understanding towards cosmetic notification and compilation of PIF among these companies by organizing workshops with hands on practice. Re-audits are scheduled to monitor and ensure compliance to the PIF requirements among these weaker companies.

There was a decrease in the number of PIFs audited in 2012. This drop is due to poor response from notification holders during audit calling. As a counter measure, NPCB has improved the audit calling procedure and taken other drastic measures such as issuance of warning letters to companies who fail to respond to the audit request. NPCB is in the process of issuing a directive informing notification holders that their product notifications will be cancelled if they fail to comply with the PIF audit. NPCB needs to enforce this procedure for the interest of all parties and enforce discipline amongst the industry. This in turn will elevate the standard of the industry.

Monitoring of Cosmetic Advertisements

Starting from year 2012, NPCB have started monitoring cosmetic advertisements to safeguard consumer interest by ensuring that all advertisements published in local newspapers, magazines, websites and electronic media are precise, true, not misleading and fulfills the cosmetic notification requirements. All claims made must be sufficiently supported.

In 2012, a total of 43 cosmetic product advertisements were monitored. From these monitoring activities, NPCB found that 15 (35%) products were advertised with claims that were found to be beyond the cosmetic scope and the responsible companies were issued a warning letter, 15 (35%) products were not cosmetic products and its notification was subsequently cancelled, 7 (16%) products were not notified and enforcement action was taken and lastly 6 (14%) cosmetics was found to be sold and marketed in a website that was based overseas (Figure 6).

Susulan daripada penemuan audit, BPFK telah mengambil inisiatif untuk menganjurkan bengkel kepatuhan kepada notifikasi kosmetik bersama sesi latihan hands-on kepada industri-industri kecil sederhana bagi meningkatkan pemahaman terhadap keperluan notifikasi kosmetik dan penyediaan Fail Maklumat Produk. Sesi audit semula dijalankan bagi memastikan bahawa terdapat peningkatan dalam tahap pematuhan terhadap penyediaan Fail Maklumat Produk bagi syarikat tersebut.

Terdapat penurunan dari segi bilangan produk yang diaudit pada tahun 2012. Penurunan ini disebabkan oleh kekurangan kerjasama daripada pihak syarikat. BPFK telah mengambil langkah penambaikan dalam prosedur pemakluman audit dan tindakan drastik dimana surat amaran akan dikeluarkan kepada pihak syarikat sekiranya mereka gagal untuk memberi maklumbalas. Pihak BPFK juga dalam proses mengeluarkan direktif yang memaklumkan pemegang notifikasi bahawa notifikasi produk akan dibatalkan sekiranya syarikat gagal untuk mengemukakan Fail Maklumat Produk.

Pemantauan Iklan Produk Kosmetik

Mulai tahun 2012, BPFK turut menjalankan pemantauan iklan-iklan produk kosmetik untuk memastikan bahawa semua tuntutan yang disiarkan di akhbar tempatan, majalah, laman sesawang dan juga media elektronik adalah tepat, benar, tidak mengelirukan dan mematuhi keperluan yang ditetapkan untuk produk kosmetik. Semua tuntutan perlu disokong dengan dokumen yang mencukupi.

Pada tahun 2012, sejumlah 43 iklan produk kosmetik telah dipantau. Hasil daripada pemantauan iklan, BPFK telah mengeluarkan surat amaran iklan kepada pemegang notifikasi untuk 15 (35%) produk yang didapati telah membuat tuntutan yang melampaui skop takrifan kosmetik, 15 (35%) produk lagi didapati bukan kosmetik dan telah dibatalkan notifikasinya, 7 (16%) produk yang diiklankan adalah tidak bernotifikasi dan telah diambil tindakan penguatkuasaan dan 6 (14%) lagi produk didapati diiklankan di laman sesawang yang beroperasi di luar negara (Rajah 6).


Rajah 6: Hasil Pemantauan Iklan Produk Kosmetik Tahun 2012Figure 6: Findings from Cosmetic Advertisement Monitoring in 2012

15 (35%)

6 (14%) 7 (16%)

15 (35%)

Beyond CosmeticScope/Melampaui Skop TakrifanKosmetikOthers/ Lain-lain

Not Notified Cosmetics/ TidakBernotifikasi

Not Cosmetic/ Bukan Kosmetik

Rajah 7: Bilangan Permit Untuk Ujian Pemasaran dan Penilaian ‘In-House’ yang Telah Dikeluarkan (2008-2012)Figure 7: Number of Market Sampling Permit and In- House Evaluation Permit Issued (2008-2012)

5,743 6,024

4,482 4,4194,069

0

1000

2000

3000

4000

5000

6000

7000

2008 2009 2010 2011 2012

Market Sampling andIn-House Evaluation/Permit ujianpemasaran atau "InHouse Evaluation"

Issuance of the Market Sampling and In House Evaluation Permit and Certification of Free Sales for Cosmetic Products

The NPCB also facilitates and encourages the cosmetic industry in establishing their businesses through the issuance of market sampling/in house evaluation permits for consumer or in house testing purposes and in export through the issuance of Certificate of Free Sales (CFS).

i. Issuance of Market Sampling Permit and In- House Evaluation Permit

A total of 4,069 permits for both market sampling and in-house evaluation permits were issued to requesting companies in year 2012 .There is slight drop in the number of permits issued as compared to the previous year (Figure 7).

Pengeluaran Permit bagi Ujian Pemasaran dan Penilaian ”In House” serta Sijil Penjualan Bebas untuk Produk Kosmetik

Bagi membantu dan menggalakkan perkembangan industri kosmetik di Malaysia, BPFK juga memberikan perkhidmatan seperti pengeluaran permit bagi Ujian Pemasaran dan Penilaian ”in-house evaluation” kepada pihak syarikat untuk mengimport/mengilangkan produk kosmetik bagi tujuan mendapatkan maklumbalas dari pengguna sebelum pemasaran atau untuk penilaian ”in house” dan Sijil Penjualan Bebas untuk pasaran ekspot.

i. Pengeluaran Permit bagi Ujian Pemasaran dan Penilaian ‘In-house’ untuk produk kosmetik

Sejumlah 4,069 permit untuk tujuan Ujian Pemasaran dan Penilaian ‘in-house’ telah dikeluarkan kepada pihak syarikat pada tahun 2012. Jumlah pengeluaran tersebut tidak jauh berbeza dengan jumlah permit yang dikeluarkan berbanding dengan tahun lepas (Rajah 7).



Rajah 8: Bilangan Sijil Penjualan Bebas untuk Produk Kosmetik Yang Dikeluarkan (2008-2012)Figure 8: Number of Certificate of Free Sales Issued (2008-2012)

1,6671,936 1,913

2,694 2,603

0

500

1000

1500

2000

2500

3000

2008 2009 2010 2011 2012

Certificate of FreeSales (CFS) / SijilPenjualan Bebas(CFS)

Rajah 9: Bilangan Pengesahan Status Notifikasi Kosmetik (2011-2012)Figure 9: Number of Cosmetic Notification Status Verifications (2011-2012)

1,231

1,292

1,200

1,220

1,240

1,260

1,280

1,300

2011 2012

Confirmation ofNotification Status/Pengesahan StatusNotifikasi

ii. Issuance of Certificate of Free Sales

A total of 2,603 certificates were issued in 2012 (Figure 8). This figure shows a slight drop from the previous year. 99% of the certificates were issued within the time frame which is less than 15 working days.

ii. Pengeluaran Sijil Penjualan Bebas untuk Produk Kosmetik

Sebanyak 2,603 Sijil Penjualan Bebas telah dikeluarkan pada tahun 2012 (Rajah 8). Terdapat sedikit penurunan dalam bilangan Sijil Penjualan Bebas yang dikeluarkan berbanding dengan tahun sebelumnya. 99% sijil tersebut telah dikeluarkan mengikut tempoh yang ditetapkan iaitu 15 hari bekerja.

Kerjasama antara BPFK dan Bahagian Penguatkuasa Farmasi

BPFK dan Bahagian Penguatkuasa Farmasi sentiasa bekerjasama dalam menjalankan aktiviti pengawasan mutu produk kosmetik di pasaran bagi memastikan semua produk kosmetik di pasaran mematuhi keperluan undang-undang yang ditetapkan.

Pada tahun 2012, BPFK telah memproses sejumlah 1,292 permohonan pengesahan status notifikasi yang telah dipohon oleh Bahagian Penguatkuasa Farmasi untuk tindakan undang-undang (Rajah 9).

Cooperation between NPCB and Pharmacy Enforcement Division

The NPCB works closely with the Pharmacy Enforcement Division ultimately aimed to protect the safety and wellbeing of the public by ensuring that all cosmetics sold in this country are notified and safe for use.

In year 2012, a total of 1,292 seized products were sent to NPCB for status verification for further legal action by the Pharmacy Enforcement Division (Figure 9).


Jadual 1: Penglibatan Pegawai-Pegawai Seksyen Kosmetik Dalam Aktiviti- Aktiviti Yang Diadakan Sepanjang Tahun 2012Table 1: Activities Conducted in 2012

Bil.No .

Bengkel/Taklimat/KonferensWorkshop/Briefing/Conference

TarikhDate

1.

Memberi taklimat berkenaan dengan notifikasi kosmetik sempena Mesyuarat Kawalan Iklan Di Bawah Akta Ubat (Iklan & Penjualan)Gave a briefing about cosmetic notification in conjunction with Meeting for Advertisement Control under Medicines (Advertisement and Sales) Act

13 February 2012

2.

Terlibat sebagai penganjur bagi mesyuarat Special ASEAN Cosmetic Committee (ACC) Heads Of Delegation yang diadakan di MalaysiaInvolved as an Organiser for the Special ASEAN Cosmetic Committee (ACC) Heads Of Delegation Meeting in Malaysia

20 - 21 February 2012

3.

Memberi ceramah bertajuk Cosmetic Ingredients and Product Safety sempena The Penang International Halal ConferenceGave a presentation entitled “Cosmetic Ingredients and Product Safety “ in The Penang International Halal Conference

25 February 2012

4.

Memberi ceramah berkenaan Updates on ASEAN Cosmetic Directive semasa Mesyuarat Agong Cosmetics, Toiletries, and Fragrance Association (CTFA) Gave a presentation entitled Updates on ASEAN Cosmetic Directive during the Cosmetic, Toiletries, and Fragrance Association (CTFA) Annual General Meeting (AGM)

13 March 2012

5. Ahli Panel untuk rancangan televisyen terbitan RTM ‘Apa Kata Wanita’Panelist for RTM Television Program ‘Apa Kata Wanita’ 29 April 2012

6

Memberi ceramah bertajuk ‘Control of Cosmetic Product in Malaysia’ di International Beauty Expo 2012Gave a presentation entitled ‘Control of Cosmetic Products in Malaysia’ in the International Beauty Expo 2012

7 May 2012

7.

Memberi taklimat bertajuk Tuntutan dan Pengiklanan Kosmetik bagi sesi penerangan mengenai rancangan tajaan RTM Gave a briefing about Cosmetic Claims and Advertising for an RTM Television Program

16 May 2012

8.

Sebagai deligasi mewakili Malaysia bagi mesyuarat ASEAN Cosmetic Committee (ACC) kali ke-17 dan mesyuarat ASEAN Cosmetic Scientific Body (ACSB) kali ke- 16 di Siem Reap, CambodiaDelegate representing Malaysia for the 17th ASEAN Cosmetic Committee (ACC) Meeting & 16th ASEAN Cosmetic Scientific Body (ACSB) Meeting , Siem Reap, Cambodia

10 - 12 July 2012

9.

Menghadiri Mesyuarat Khas ACCSQ WG2 – Working Group On Accreditation And Conformity Attendee for the Special Meeting for ASEAN Consultative Committee on Standards and Quality (ACCSQ) WG2 – Working Group On Accreditation And Conformity (WG2)

11 - 12 September 2012



Bil.No .

Bengkel/Taklimat/KonferensWorkshop/Briefing/Conference

TarikhDate

10.

Memberi ceramah bertajuk Control of Cosmetic Products in Malaysia di Konferens 1st International Conference On Nutraceutical And Cosmetic SciencesGave a presentation entitled Control of Cosmetic Products in Malaysia for the 1st International Conference On Nutraceutical And Cosmetic Sciences

23 September 2012

11.

Memberi Latihan kepada pegawai di Pusat Komplians dan Pelesenan, BPFK : ACD Guidelines for Product Information File (PIF) Gave training to staffs from Centre of Compliance and Licensing on ACD Guidelines for Product Information File (PIF)

24 September 2012

12. Penceramah bagi Kursus Amalan Edaran BaikPresenter for Good Distribution Practice Course 3 October 2012

13.

Penceramah bagi seminar yang dianjurkan oleh Direct Selling Association of Malaysia – Training and Talk Series : Notification Procedure for CosmeticsPresenter for Training and Talk Series : Notification Procedure for Cosmetics organized by Direct Selling Association of Malaysia

30 October 2012

14.

Memberi taklimat bertajuk Tuntutan dan Pengiklanan Kosmetik bagi Program Dialog bersama pihak AstroGave a briefing about Cosmetic Claims and Advertising for a Dialogue Program with Astro

31 October 2012

15.

Sebagai deligasi mewakili Malaysia bagi mesyuarat ASEAN Cosmetic Committee (ACC) kali ke-18 dan mesyuarat ASEAN Cosmetic Scientific Body (ACSB) kali ke- 17 di Solo, Indonesia.Delegate representing Malaysia for the 18th Acc Meeting & 17th ACSB Meeting ,Solo, Indonesia (Delegate)

19 – 22 November 2012

16.

Penceramah bagi 2012 International Cosmetic PIF, Notification And GMP Practices Management Training Workshop yang dianjurkan oleh Taiwan FDAPresenter for 2012 International Cosmetic PIF, Notification And GMP Practices Management Training Workshop organised by Taiwan FDA

4 – 6 December 2012



VARIASIVARIATION


VARIASI VARIATION

The main activity of the Variation Section is to evaluate any applications for change of information, including information updates for registered products (excluding cosmetics and veterinary products), to ensure the safety, quality and efficacy of the product after it has been registered.

Examples of information changes include updating the package inserts, changes to the product formulation, change of product label, increase in pack size or primary packaging material, and change of manufacturing site.

A total of 60,300 variation applications for Quest 2 products were received in 2012. Out of these, 68% were for prescription products, followed by 15% for traditional products, 13% for non-prescription items, and 4% for health supplements (Figure 1).

Aktiviti utama Seksyen Variasi adalah menilai permohonan bagi sebarang perubahan maklumat termasuk mengemaskini maklumat produk berdaftar (kecuali produk kosmetik dan veterinar) bagi memastikan keselamatan, keberkesanan dan kualiti produk selepas didaftarkan.

Di antara perubahan-perubahan maklumat produk berdaftar termasuk penambahan maklumat di dalam sisip bungkusan, perubahan pada formulasi produk, pertukaran label produk, penambahan saiz pek atau bahan pembungkus primer dan pertukaran tapak pengilangan.

Pada tahun 2012, sebanyak 60,300 permohonan variasi produk Quest 2 telah diterima. Sebanyak 68% bilangan permohonan tersebut adalah daripada produk preskripsi, diikuti dengan permohonan variasi bagi produk tradisional sebanyak 15%, bukan preskripsi sebanyak 13% dan supplemen kesihatan sebanyak 4% (Rajah 1).

Rajah 1: Permohonan Variasi bagi Produk Quest 2 yang Diterima pada Tahun 2012Figure 1: Variation Applications for Quest 2 Products Received in 2012

Sebanyak 48,023 daripada jumlah permohonan yang diterima telah diproses pada tahun 2012. Daripada jumlah ini, sebanyak 25,335 (53%) permohonan telah diluluskan sepanjang tahun 2012 (Rajah 2).

Terdapat penurunan bilangan permohonan variasi yang diluluskan dari tahun 2010 hingga 2012 (Rajah 2). Antara faktor-faktor yang menyebabkan penurunan kelulusan permohonan variasi adalah:

A total of 48,023 of variation applications received were processed in 2012. Of these, 25,335 (53%) applications were approved (Figure 2).

There was a decrease in the number of variation applications approved from 2010 to 2012 (Figure 2). Among the contributing factors for the decrease were:



Rajah 3: Permohonan Variasi Bagi Produk Quest 3 Yang Diproses Pada Tahun 2012 Figure 3: Variation Applications for Quest 3 Products Processed in 2012

Rajah 2: Permohonan Variasi Diterima berbanding bilangan diproses serta lulusFigure 2: Comparison of Variation Applications Received, Processed and Approved

i. Documents submitted by the applicants were incomplete and did not comply with the regulations;

ii. Requests from applicants themselves to reject applications which were submitted with incorrect documents or data;

iii. The current assessment of variation applications is more thorough and detailed

For Quest 3 products, a total of 428 variation applications were processed. 45% of these were for prescription products, 14% health supplements, and 1% non-prescription items (Figure 3).

i. Pemohon mengemukakan dokumen yang tidak lengkap dan tidak mematuhi keperluan regulatori.

ii. Permintaan dari pemohon sendiri untuk menolak permohonan kerana tersalah mengemukakan dokumen atau data.

iii. Penilaian permohonan variasi adalah lebih menyeluruh dan terperinci.

Bagi produk Quest 3, sebanyak 428 permohonan variasi telah diproses. Sejumlah 45% bilangan permohonan tersebut adalah daripada produk preskripsi, diikuti dengan permohonan variasi bagi produk tradisional sebanyak 40%, supplemen kesihatan sebanyak 14% dan bukan preskripsi sebanyak 1% (Rajah 3).


There has been an increase in the number of variation applications received each year due to the increase in total registered products, increase in post-registration regulatory activities (surveillance and pharmacovigilance), as well as adherence to latest circulars and directives issued by the DCA and NPCB. Among these directives are the implementation of Consumer Medication Information Leaflets (RiMUP) and the requirement for bioequivalence (BE) studies for all generic products.

There was an increase of 12.3% in the number of variation applications received in 2012 compared to 2011. Besides the factors mentioned above, contributing factors to this increase include resubmission of variation applications, and applications to change the product owners and product registration holders for a large number of products. However, the number of applications processed remained consistent from 2008 to 2012.

The number of applications for change of manufacturing site received in 2012 increased by 24.4% compared to 2011 (Figure 4). Among the factors contributing to this increase include:

a) transfer of premises due to company mergers or company strategy;

b) upgrading of the current premises;c) compliance of the premises to PICS requirements

Terdapat peningkatan bilangan permohonan variasi yang telah diterima dari setahun ke setahun disebabkan oleh penambahan jumlah produk yang didaftarkan, peningkatan aktiviti pasca pendaftaran (surveilans dan farmakovigilans) serta pematuhan kepada pekeliling pelaksanaan yang terkini daripada Pihak Berkuasa Kawalan Dadah (PBKD) dan Biro Pengawalan Farmaseutikal Kebangsaan (BPFK). Antara arahan-arahan yang dikeluarkan adalah pelaksanaan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dan keperluan kajian bioequivalens (BE) bagi semua produk generik.

Terdapat peningkatan permohonan variasi yang diterima pada tahun 2012 berbanding tahun 2011 sebanyak 12.3%. Selain daripada faktor-faktor yang telah dinyatakan di atas, pengemukaan semula permohonan variasi, permohonan pertukaran pemilik produk dan pemegang pendaftaran produk untuk sejumlah produk yang besar juga merupakan pendorong utama bagi peningkatan tersebut, Walau bagaimanapun, bilangan permohonan yang diproses adalah konsisten dari tahun 2008 hingga 2012.

Bilangan permohonan pertukaran tapak pengilangan yang diterima pada tahun 2012 telah meningkat sebanyak 24.4% berbanding tahun 2011 (Rajah 4). Di antara faktor-faktor yang mendorong kepada peningkatan yang ketara dalam bilangan permohonan pertukaran tapak pengilangan ialah:

a) pemindahan lokasi pengilangan disebabkan oleh percantuman syarikat atau strategi syarikat.

b) pengembangan lokasi yang sedia ada. c) pematuhan premis terhadap keperluan PICS

Rajah 4: Permohonan Pertukaran Tapak Pengilang Yang Diterima Daripada Tahun 2006-2012Figure 4: Change of Manufacturing Site Applications Received from 2006-2012



PENYEBARAN MAKLUMAT, LATIHAN & LAWATAN

INFORMATION DISSEMINATION, TRAININGS & VISITOR


Management of the Information Technology (IT) System

The IT section is in charge of the hardware, software and networking of computers in NPCB. They provide support, which includes repairing, maintaining, troubleshooting problems and providing solutions to the staff within the institution. The QUEST3 system, NPCB’s online system, is also under the care of this section. Apart from that, the IT section also administers the Helpdesk which is the main source of information for the public. The helpdesk officers play an important role in providing guidance to applicants who are interested in registering products as well as answering questions from the public via telephone, email, fax and also at the counter.

Pengurusan Sistem Teknologi Maklumat

Seksyen IT bertanggungjawab ke atas perkakasan, perisian serta rangkaian komputer di BPFK. Seksyen ini juga menyediakan sokongan dari segi membaiki dan menyelesaikan masalah-masalah berkaitan komputer serta rangkaian internet dan intranet kepada kakitangan BPFK. Seksyen ini juga bertanggungjawab ke atas sistem atas talian BPFK iaitu sistem QUEST 3. Selain itu, seksyen IT juga menguruskan Helpdesk yang merupakan sumber maklumat utama bagi orang awam. Kakitangan Helpdesk memainkan peranan penting dalam memberikan bantuan kepada para pelanggan yang ingin mendaftarkan produk mereka. Selain itu, mereka juga menjawab soalan-soalan yang dikemukakan oleh orang awam melalui telefon, email, faks serta pelanggan yang walk-in ke kaunter.

Rajah 1: Bilangan Aduan QUEST 2/ QUEST 3 yang diselesaikan (2008-2012)Figure 1: Number of Resolved QUEST2 / QUEST 3 Complaints (2008-2012)

Pengurusan Laman Web BPFK

Seksyen IT juga menguruskan laman web BPFK dengan memastikan bahawa artikel baru, dokumen-dokumen penting dan maklumat regulatori sentiasa dikemaskini. Rupa bentuk laman web BPFK telah pun diperbaharui dan dapat diakses oleh pengguna bermula September 2012. Butang pada laman web mempunyai warna yang berbeza dan disusun secara sistematik. Ciri baru ini bukan sahaja lebih menarik malah ianya mesra pengguna.

Maintenance of the NPCB website

The IT section also oversees the NPCB website to ensure new articles, documents and other relevant regulatory information is constantly updated. The website has been given a facelift and was accessible to public starting September 2012. The new look is not only more attractive but also user friendly. The tabs are arranged in a systematic manner and the links are of different colors to simplify the navigation throughout the website.

Bilangan Aduan yang diselesaikanNumber of Resolved Complaints



Rajah 2: Rupabentuk Laman Web TerkiniFigure 2 : Updated Website Design

Pengurusan Pertanyaan

Pusat Pembangunan Organisasi memainkan peranan yang penting dalam menguruskan pelbagai jenis pertanyaan yang diterima daripada pengamal kesihatan, pihak industri dan orang awam melalui telefon, e-mail, fax/surat serta para pelanggan yang walk-in ke kaunter. Sepanjang 2012, sebanyak 4,024 pertanyaan yang telah diterima seperti yang tertera di dalam jadual di bawah.

Handling of Enquiries

The Centre for Organisational Development plays a significant role in handling enquiries made by healthcare professionals, industry players and the general public. These enquiries are received via different channels such as phone, e-mail, fax/letter, and walk-in customers. In 2012, a total of 4,024 enquiries had been received through the various channels as shown in the table below.

Year No. of enquires

2011 19802012 4189

Telefon / Telephone


2011 3702012 832

Emel / E-mail


2011 6822012 950

Pertanyaan kaunter / Walk-in


Penerbitan Berita Ubat-Ubatan dan Laporan Tahunan BPFK

Sebanyak 3 edisi Berita Ubat-Ubatan (majalah mengenai polisi PBKD) dan satu naskah Laporan Tahunan BPFK telah diterbitkan untuk edaran pada tahun 2012.

Pengurusan dan Penyelarasan Sesi Dialog dengan Pihak Industri

Sebagai landasan penyebaran maklumat terkini, BPFK telah mengadakan sesi dialog bersama pihak industri tempatan, persatuan industri, pengguna dan pihak-pihak yang berkenaan. Ini adalah bagi memastikan pihak industri sentiasa dimaklumkan apabila terdapat pengemaskinian dalam sistem regulatori. Sepanjang tahun 2012, BPFK telah menganjurkan 10 sesi dialog bersama pesatuan-persatuan berikut :

Publications, namely the NPCB Annual Report, and the Berita Ubat-Ubatan

A total of 3 editions of Berita Ubat-Ubatan (magazine concerning DCA policies) were published in the year 2012, along with one edition of the NPCB Annual report.

Organising and Coordinating Dialogues with Relevant Industrial Associations

As a platform for information sharing and promulgation of new updates, NPCB conducted several dialogues sessions with local industry, industry association, consumers and other stakeholders. This is to ensure the industry, as well as the public, are constantly updated with the current regulatory affairs. In 2012, a total of 10 dialogues sessions were held with the following associations:

Jadual 1: Dialog di antara BPFK dengan Persatuan-persatuan pada tahun 2012Table 1 : Dialogues between NPCB and Assosications in 2012

Bil.No.

Persatuan / Industri / Bahgian lainAssociation / Industry / Other Division

TarikhDate

1. Malaysian Association of Pharmaceutical Suppliers (MAPS) 27 March 2012

2. Malaysian Animal Health and Nutrition Industries Association (MAHNIA) 16 May 2012

3. Pharmacy Enforcement Divison 24 May 2012

4.‘Persatuan Pengeluar Ubat Cina Malaysia’ (PPUCM) dan Federation of Chinese Physicians and Medicine Dealers Association of Malaysia (FCPMDAM)

25 July 2012

5. Malaysian Organization of Pharmaceutical Industry (MOPI) 7 August 2012

6. Pharmaceutical Association of Malaysia (PhAMA) 15 August 2012

7. ‘Majlis Perubatan Homeopati Malaysia’ (MHPM) 10 October 2012

8.‘Persatuan Pengeluar-pengeluar Ubat Tradisional Melayu Malaysia’ (PURBATAMA) dan ‘Gabungan Pertubuhan Pengamal Perubatan Melayu Malaysia’ (GAPERA)

22 November 2012

9. Malaysian Association of Pharmaceutical Suppliers (MAPS) 13 December 2012

10. Pharmacy Enforcement Divison 19 December 2012

Penyelarasan Latihan, Seminar dan Kursus

Latihan berterusan amat penting bagi pegawai farmasi dan penolong pegawai farmasi bagi memastikan kakitangan BPFK sentiasa memperoleh maklumat yang terkini dalam bidang farmaseutikal dan bidang-bidang lain yang berkaitan. Pusat Pembangunan Organisasi bertanggungjawab untuk menyelaras latihan, seminar

Coordinate Trainings, Seminars and Courses

Continuous training for pharmacists and assistant pharmacists are crucial in order for NPCB staff to be kept updated on the latest information in pharmaceutical and other related fields. The Centre for Organisational Development is responsible for coordinating these trainings, seminars and courses for the staff as part



dan kursus di bawah program the Continuous Professional Development (CPD). Pada tahun 2012, sebanyak 149 sesi CPD telah dianjurkan. Ini termasuk ceramah, seminar, bengkel dan Kelab Jurnal yang telah diadakan di BPFK mahupun di lokasi luar.

Kursus Amalan Klinikal Baik (GCP)

Tiga puluh tiga kursus GCP yang melibatkan sebanyak 1,756 orang peserta telah dianjurkan oleh Pusat Penyelidikan Klinikal, Kementerian Kesihatan Malaysia dan Pihak Universiti pada tahun 2012 di mana Pusat Kajian Produk Baru, BPFK memainkan peranan penting dalam memberi ceramah dan mengawasi peperiksaan GCP. Bermula pada tahun 2012, sijil untuk semua peserta yang lulus dalam peperiksaan GCP akan dikeluarkan oleh BPFK yang bertindak sebagai secretariat kepada National Committee for Clinical Research (NCCR). Dengan ini, BPFK telah mengeluarkan sebanyak 1,530 sijil GCP termasuk sijil kepada peserta yang lulus dalam peperiksaan berulang. Kursus ini diadakan bertujuan untuk memberi pendedahan dan latihan tentang prinsip-prinsip GCP kepada para penyelidik serta kakitangan-kakitangan yang terlibat dalam kajian klinikal. Hal ini adalah penting untuk memastikan kajian klinikal yang dijalankan di Malaysia diterima dan diiktiraf di peringkat antarabangsa.

Pemeriksaan Amalan Pengedaran Baik (AEB)

Seksyen AEB telah berjaya mengadakan sebanyak 7 sesi latihan dan ceramah kepada pihak persatuan, industri dan juga agensi kerajaan sepanjang tahun 2012. Sesi latihan ini adalah bertujuan untuk meningkatkan kesedaran dan pengetahuan pihak terlibat ke arah pematuhan Amalan Pengedaran Baik dengan lebih berkesan.

of the Continuous Professional Development (CPD) Program. In the year 2012, a total of 149 CPD sessions were conducted. The sessions included educational talks, seminars, workshops and Journal Club sessions conducted both externally and in-house.

Good Clinical Practice (GCP) Course

Thirty three GCP courses which involved 1,756 participants had been organized by Clinical Research Centre, MOH and Universities in year 2012 where the Centre for Investigational New Product (CINP), NPCB played an important role in giving lectures and invigilating the GCP examinations. Starting from year 2012, the certificates for all participants who passed the GCP examination were issued by NPCB who acted as a secretariat to the National Committee for Clinical Research (NCCR). NPCB had issued a total of 1,530 certificates which included the certificates for participant who repeated the examination. These courses were organised to provide exposures and trainings on the Principles of GCP to all researchers and staffs who involved in clinical trials. This was important to ensure that the clinical trials in Malaysia will be accepted and recognised internationally.

Good Distribution Practice (GDP) Inspection

The GDP section has successfully held 7 training sessions and talks to parties of associations, industries and government agencies throughout the year 2012. These training sessions is designed to increase awareness and knowledge of parties involved towards compliance to GDP more effectively.

Rajah 3: Bilangan sesi latihan (CPD) (2008 – 2012)Figure 3 : Number of Continuous Professional Development (CPD) Sessions


Penyelarasan Lawatan Pelawat Tempatan dan Pelawat Antarabangsa

BPFK telah dilantik sebagai Pusat Kolaborasi Regulatori WHO dalam bidang famaseutikal di Malaysia. BPFK memberikan latihan secara berterusan kepada pelawat tempatan dan juga antarabangsa di dalam bidang amalan perkilangan baik, analisis produk farmaseutikal, pendaftaran produk serta sistem perlesenan yang dipraktiskan di Malaysia. Sepanjang 2012, BPFK telah menerima 82 pelawat tempatan dan 48 pelawat dari luar negara. Pelawat antarabangsa terdiri daripada delegasi daripada negara Asia seperti Indonesia, Taiwan, Brunei, Korea & Singapura serta delegasi daripada perantauan lain seperti Ethiopia, Bhutan, Pakistan, Egypt, Poland, Turkey, Czech Republic dan Slovenia.

Coordinate Visits by Local and International Visitors

NPCB is the World Health Organisation Collaborating Center for Regulatory Control of Pharmaceuticals in Malaysia. NPCB continually provides training to local and international visitors in areas relating to manufacturing practices, pharmaceutical analysis, product registration, and the licensing system practiced in the country. Throughout 2012, NPCB has been honored to receive a total of 82 local visitors and 48 international visitors. The international visitors includes delegates from Asia such as Indonesia, Taiwan, Brunei, Democratic People’s Republic of Korea & Singapore as well as delegates from other regions such as Ethiopia, Bhutan, Pakistan, Egypt, Poland, Turkey, Czech Republic and Slovenia.

Rajah 4 : Bilangan pelawat (2008 – 2012)Figure 4: Number of visitors (2008 - 2012)

Tahun / Year



Pelawat AntarabangsaInternational Visitors

OrganisasiOrganisation

Bil. PelawatNo. of Visitors

NegaraCountry

TarikhDate

Food, Medicine and Health Care, Administration Central Authority of Ethiopia

3 Ethiopia 10 -13 January 2012

Ministry of Public Health, SoChang Dong, Central District, Pyongyang, DPR Korea 3 DPR Korea

9 – 20 April 2012

National Agency of Drug and Food Control 5 Indonesia 12 June 2012

- Sub-division of Consumerism and Product Distribution Control

- Sub-division of Industrial and Business Facilitation

- Indonesian Embassy

3 Indonesia 21 June 2012

Pharmacy Undergraduate Students (Students Exchange Program To Malaysia)

8 - Egypt- Indonesia- Netherlands - Turkey- Czech Republic- Poland- Slovenia- Czech Republic

8 August 2012

Ministry of Health Brunei 5 Brunei Darussalam 3 – 7 September 2012

- Taiwan FDA- Taiwan Generic Pharmaceutical Association

4 Taiwan 22 October 2012

Drug Regulatory Authority, Bhutan 2 Bhutan 29 October – 9 November 2012

Health Sciences Authority, Singapore 8 Singapore 19 November 2012

- Nabiqasim Industries Pvt Ltd- High Commission for Pakistan- Efroze Chemical Industries Pvt Ltd- Sante Pvt Ltd- Nexus Pharma Pvt Ltd

7 Pakistan 21 November 2012


Pelawat Tempatan / Local Visitors

OrganisasiOrganisation

Bil. PelawatNo. of Visitors

TarikhDate

Department of Islamic Development Malaysia (JAKIM) 10 10 January 2012

Institute of Bioscience, Universiti Putra Malaysia (UPM) 9 30 May 2012

Pharmacy Undergraduate Students International Pharmaceutical Students’ Federation (IPSF) with the help of Malaysian Pharmacy Students’ Association (MyPSA), Chapter Of Malaysian Pharmaceutical Society (MPS)

9 8 August 2012

Cyberjaya University College of Medical Sciences (CUCMS)

35 27 September 2012

’Institut Penyelidikan Sains Dan Teknologi Pertahanan’ (STRIDE)

8 8 October 2012

Melaka Pharmacy Enforcement Division 10 17 December 2012



LAPORAN KEWANGANFINANCIAL REPORT


Laporan Kewangan | Financial Report

TINJAUAN BELANJAWAN / BUDGET PREVIEW

Peruntukan dan Perbelanjaan Mengurus BPFK bagi Tahun 2012NPCB Operating Allocation and Expenditure 2012

Kod ObjekObject Code

Jenis PerbelanjaanExpenditure

Peruntukan (RM)Allocation (RM)

Perbelanjaan (RM)Expenditure (RM)

Baki Balance

AsalOriginal

DipindaAmended

Perbelanjaan Bersih (RM)

Actual Expenditure (RM)

% (RM) %

10000 EmolumenEmolument

9,651,000 16,625,000 20,379,441.77 122.58 (3,754,441.77) (22.58)

20000 Perkhidmatan & Bekalan

Services & Supply

9,280,000 9,670,390 9,538,415.04 102.78 131,974.96 1.36

30000 Aset (Harta Modal)

Asset (Property)

156,400 113,527 113,526.50 72.59 0.50 0.00

40000Pemberian &

Kenaan Bayaran Tetap

(Gift and Fixed Payment)

306,000 301,000 201,916.95 65.99 99,083.05 32.92

JumlahTotal

19,393,400 26,709,917 30,233,300.26 155.89 (3,523,383.26) (13.19)

Sepanjang tahun 2012, BPFK telah menerima peruntukan sebanyak RM 26,709,917.00 untuk perbelanjaan Mengurus manakala RM 1,614,988.00 untuk projek Pembangunan. Pecahan bagi peruntukan tersebut seperti jadual di bawah:

In 2012, NPCB had received an allocation of RM 26,709,917.00 for Operating Expenditure and RM 1,614,988 for Development Expenditure. The breakdown of the allocation is as follows:



Peruntukan dan Perbelanjaan Pembangunan BPFK bagi Tahun 2012NPCB Development Allocation and Expenditure 2012

Kod ProjekProject Code

Jenis PerbelanjaanExpenditure

Peruntukan (RM)Allocation (RM)

Perbelanjaan (RM)Expenditure (RM)

Baki (RM)Balance (RM)

AsalOriginal

DipindaAmended

Perbelanjaan Bersih (RM)

Actual Expenditure

(RM)

% %

00105 Latihan dalam Perkhidmatan

Inservice Training

70,000 133,488 116,411.65 166.3 17,076.35 12.79

94000 Monograph Herba Malaysia

Malaysian Herbal Monograph

433,500 433,500 426,166.25 98.3 7,333.75 1.69

01100 Pembelian Peralatan Analisis

& Naiktaraf Makmal

Purchasing Analysis

Equipment & Upgrading Laboratory

4,548,000 1,048,000 1,045,820 23.0 2,180 0.21


Kutipan Hasil BPFK diterima melalui pelbagai bayaran untuk pendaftaran produk, notifikasi kosmetik, perlesenan perkhidmatan makmal dan dan bayaran- bayaran yang lain.

NPCB obtained its revenue from various payments for product registrations, cosmetic notifications, licenses, laboratory tests as well as other payments.

RINGKASAN KUTIPAN HASIL TAHUN 2012SUMMARY OF REVENUE FOR THE YEAR 2012

PENGKELASAN KOD HASIL TAHUN 2012CLASSES OF REVENUE 2012 JUMLAH KEMASKINI

TotalKODCode

PERKARAItem

73199 Jualan Bahan Cetak Selling Printed Materials 100.00

72499 Proses Perkhidmatan Makmal Laboratory Test 32,810.00

Amalan Perkilangan Baik Good Manufacturing Practice 546,250.00

Lesen Borong Wholesale License 482,500.00

71499 Lesen Import Import License 212,000.00

Lesen Import Klinikal Clinical Trial License 155,500.00

Lesen Kilang Factory License 278,000.00

Daftar Ubat Product Registration 9,252,200.00

72199

Perakuan Penjualan Free Sale Certificate 247,750.00

Tukar Pemegang Change of Holder 783,000.00

Pertukaran Tapak Kilang Change of Site 145,000.00

Daftar Ubat Eksport Export Product Registration 67,300.00

73999 Jualan-Jualan Lain Others Selling 17,720.00

73301 Jualan Harta Benda Kerajaan Selling of Asset 845.00

JUMLAH TOTAL 12,220,975.00



CABARANCHALLENGES


CABARAN CHALLENGES1. Cabaran utama yang dihadapi bagi pendaftaran

produk adalah memastikan jangkamasa penilaian dan pendaftaran produk mematuhi piagam pelanggan. Pusat Pendaftaran Produk ditugaskan untuk menguruskan sumber-sumber sedia ada dengan lebih baik supaya dapat mempercepatkan proses penilaian. Pemahaman pemohon tentang proses penilaian juga perlu dipertingkatkan tanpa menjejaskan kualiti, keselamatan dan keberkesanan produk.

i. Halangan utama untuk manambahbaik tempoh masa pendaftaran produk adalah ketidakstabilan sistem QUEST3. Oleh sebab kelemahan sistem tersebut, pendaftaran produk pada tahun 2012 sering kali tertangguh.

Antara tindakan-tindakan yang diambil untuk mengatasi masalah ini adalah:

a) Perbincangan dan interaksi dengan pemohon. Sesi perbincangan khas secara individu ini bertujuan untuk membimbing pemohon dari segi keperluan pendaftaran. Masalah boleh diselesaikan serta-merta dan secara tidak langsung dapat menggalakkan komunikasi yang lebih berkesan antara BPFK dan pihak industri.

b) Komunikasi dengan pemohon melalui telefon, emel atau surat.

c) Mempunyai pegawai bertugas khas menjawab pertanyaan yang diterima melalui telefon atau daripada pemohon yang datang terus ke BPFK.

d) Mengadakan sesi dialog bersama dengan pelbagai pihak berkepentingan untuk menangani masalah yang dihadapi oleh mereka semasa pendaftaran produk dan secara tidak langsung dapat meningkatkan pengurusan proses pendaftaran.

e) Penganjuran bengkel dan sesi latihan sama ada di BPFK atau di tempat-tempat yang lebih sesuai untuk pemohon. Persatuan-persatuan juga digalakkan untuk menjemput pegawai penilai untuk memberikan ceramah mengenai pendaftaran produk semasa aktiviti mereka.

1. The main challenge in product registration is to ensure that all products are registered within the timeline as specified in the client charter. Thus, the Centre for Product Registration has been tasked to better manage resources so as to expedite the evaluation process. This would also include improving applicants understanding of the evaluation process without compromising on the quality, safety and effectiveness of the product.

i. The main obstacle to improving the timeline for product registration is the instability of the QUEST3 system. Due to the inadequacies of the system, registration of products in 2012 was often delayed.

Among the measures taken to overcome this short fall include:

a) Discussions and interactions with applicants. These one-to-one sessions are intended to guide the applicant in understanding the registration requirements. Problems can be resolved on the spot and this session will also indirectly lead to better communication and good will between NPCB and the industry.

b) Communicating with the applicant via phone, e-mail or through letters.

c) Having designated duty officers to answer queries received through the phone or from walk-in applicants.

d) Having more dialogue sessions with the various stakeholders to address their problems encountered during product registration and indirectly improving the registration process itself.

e) Organising workshops and training sessions either in NPCB or at venues convenient to the applicant. Associations have also been encouraged to invite evaluators to give talks on product registration during their functions.



f) Pembentukan jawatankuasa Kerja Teknikal yang terdiri daripada pegawai-pegawai BPFK dan pihak berkepentingan untuk mencapai persetujuan bersama mengenai tempoh masa bagi pelaksanaan keperluan sedia ada dan mencapai konsensus mengenai dasar baru.

g) Mengemaskini Drug Registration Guidance Document (DRGD) melalui maklumbalas yang diterima demi menghasilkan satu garis panduan yang lebih menyeluruh untuk pemahaman keperluan pendaftaran yang lebih baik di kalangan pemohon.

h) Satu templat pendaftaran bagi produk suplemen kesihatan telah dimuat naik di laman sesawang BPFK untuk kemudahan pemohon. Ini telah dilaksanakan berikutan templat yang disediakan bagi pendaftaran produk racun dan produk racun tidak berjadual.

i) Pegawai Penilai dihantar untuk menghadiri latihan dalaman dan kursus supaya dapat meningkatkan kemahiran dalam penilaian produk.

j) Menyediakan pautan dalam laman sesawang untuk pemohon merujuk kepada sumber rujukan.

2. Bagi produk veterinar, cabaran utama adalah untuk menangani tunggakan dalam permohonan yang diterima. Tunggakan ini bertambah rumit disebabkan oleh faktor-faktor berikut:

a) Ketiadaan rujukan terutama bagi formulasi baru

b) Pemohon mengambil masa yang lama untuk menjawab pertanyaan yang diajukan.

c) Kegagalan pemohon untuk menyediakan dokumen-dokumen yang lengkap seperti yang diminta terutamanya bagi produk yang diimpot.

d) Kegagalan pengilang untuk mematuhi keperluan Amalan Perkilangan Baik (APB).

e) Perbezaan dalam keperluan regulatori bagi produk veterinar secara global.

Langkah-langkah seperti yang dinyatakan dalam perenggan sebelum ini juga diambil untuk menangani masalah yang dihadapi oleh seksyen veterinar untuk pendaftaran produk.

f) Formation of Technical Working groups and committees comprising of NPCB officials and relevant stakeholders in order to achieve mutual agreement on timelines for implementation of existing requirements and reaching consensus on new polices.

g) Continuously updating the Drug Registration Guidance Document (DRGD) through feedback received in order to produce a more comprehensive guideline for better understanding of the registration requirements by amongst the applicant.

h) A registration template for health supplement products has been uploaded on NPCB website for the convenience of applicants. This has been done following the success of templates provided for the registration of scheduled poisons and non-scheduled poisons.

i) Evaluators have been sent for in-house training and attachment courses so as to increase their proficiency in evaluating products.

j) Providing linkages in the website for applicants to source for references.

2. For veterinary products, the main challenge is to address the outstanding backlog of applications received. This backlog is further compounded by the following factors:

a) Unavailability of references especially for new formulations.

b) Applicants taking a long time to reply to queries posted.

c) Failure of applicants to provide complete documentations as requested especially for imported products.

d) Failure of manufacturers to comply with Good Manufacturing Practice (GMP) requirements.

e) Differences in regulatory control of veterinary products globally.

The measures as mentioned in the earlier paragraph are also undertaken to address the problems faced by the veterinary section for product registration.


3. Cabaran-cabaran utama yang dihadapi dalam pemantauan keselamatan produk adalah:

a) Kurang laporan kesan advers yang diterima dari sektor kesihatan swasta, terutamanya farmasi komuniti dan klinik swasta. Ini akan menjejaskan pengesanan isyarat ADR dan keputusan keselamatan ubat kebangsaan.

b) Laporan kesan advers yang diterima kurang berkualiti dan tidak lengkap. Apabila laporan yang tidak lengkap diterima, pelapor perlu dihubungi semula untuk memberikan maklumat lanjut supaya penetapan causality boleh dilakukan dengan tepat.

c) Pengesanan isyarat kesan advers dilakukan secara manual, hasilnya pengesanan isyarat adalah lambat. Pada masa ini, tidak wujud sistem automatik untuk menganalisa data kesan advers dan menjana isyarat awal. Sistem sebegini akan membolehkan tindakan awal pengurangan risiko atau tindakan regulatori diambil ke atas produk dengan isu keselamatan.

d) Walaupun bilangan laporan kesan advers yang diterima semakin meningkat setiap tahun, peningkatan bilangan staf tidak sejajar dengan beban kerja. Tugas mengesan pelapor dan mendapatkan maklumat tambahan menjadi rumit hasil daripada tunggakan dalam memproses laporan.

4. Antara cabaran utama yang dihadapi semasa pengendalian aduan produk termasuk :

a) Terdapat aduan kualiti produk diterima dan hasil siasatan mendapati masalah produk yang diadu adalah disebabkan oleh kaedah penyimpanan produk yang kurang sesuai di pihak pengadu.

b) Terdapat beberapa aduan tidak berasas yang sepatutnya disiasat terlebih dahulu di peringkat institut berkenaan.

c) Aduan label produk yang kelihatan sama, yang dikilangkan oleh syarikat yang sama atau antara syarikat yang berlainan.

d) Pelaporan melalui borang yang tidak sesuai, sebagai contoh, laporan kesan advers ubat dan aduan terhadap peralatan perubatan.

3. The main challenges faced in product safety monitoring are:

a) The low number of reports on adverse drug reactions (ADRs) received from the private healthcare sector, especially retail pharmacists and general practitioners. This under-reporting will affect the detection of ADR signals and hence national drug safety decisions.

b) Poor quality of reports received, in terms of completeness. When incomplete reports are received, the reporter has to be re-contacted to provide further details in order to allow more accurate causality assessment.

c) Detection of ADR signals is done manually, resulting in slower identification of signals. Currently, there is no efficient automated system to analyse ADR data and generate early signals which would enable risk minimisation or regulatory action to be taken on products with safety issues.

d) Although the number of ADR reports received has been growing steadily over the years, the increase in the number of staff has not been proportional to the workload. The backlog in processing cases results in difficulties in obtaining further information and tracing reporters.

4. Some of the major challenges in handling product complaints include :

a) There were complaints on quality defect of a product, in which later found to be caused by inappropriate storage condition of the product at the reporting site.

b) There were several unjustified complaints which should have been addressed at the institute level.

c) Products look alike in terms of labeling, manufactured by the same company or between different companies.

d) Inappropriate usages of the complaint form, for example, reporting on products adverse drug reaction and medical devices.



e) Aduan terhadap produk bukan di bawah bidang kuasa pihak BPFK telah diterima, contohnya, aduan dibuat terhadap peralatan perubatan dan makanan.

5. Antara cabaran utama yang dihadapi semasa melaksanakan Program Pemantauan Mutu Produk Kosmetik Bernotifikasi di pasaran adalah :

a) Memandangkan pengiklanan kosmetik tidak memerlukan sebarang kelulusan dari BPFK, syarikat yang tidak bertanggungjawab atau yang masih kurang kesedaran berkaitan keperluan pengiklanan kosmetik cenderung untuk mengiklankan produk-produk kosmetik mereka dengan tuntutan yang mengelirukan pengguna dan diragui kesahihannya serta tidak boleh disokong dengan data yang mencukupi.

b) Pihak syarikat masih kurang memahami berkenaan keperluan pelabelan kosmetik di mana masih terdapat produk-produk kosmetik di pasaran yang tidak mematuhi keperluan pelabelan yang ditetapkan.

c) Pemegang notifikasi dan pengilang juga didapati masih kurang kemahiran teknikal untuk menjalankan penilaian keselamatan terhadap produk kosmetik serta bahan-bahan yang digunakan dalam formulasi produk kosmetik.

d) Usaha untuk meningkatkan kesedaran di kalangan pengguna terutama dalam aspek keselamatan produk kosmetik juga perlu dilaksanakan dengan lebih giat dan sistematik bagi memastikan pengguna-pengguna kosmetik di Malaysia mendapat pengetahuan dan pendedahan berkenaan cara pengguna kosmetik yang betul dan selamat. Ini kerana pengguna mudah terpengaruh dan cenderung untuk menggunakan produk kosmetik yang dipercayai dapat memberikan kesan yang cepat dan ketara tanpa mengambilkira sama ada produk tersebut bernotifikasi atau tidak.

e) Complaints submitted were not directed to the appropriate authority. This includes complaints received on medical devices and food which are not under the purview of NPCB.

5. Amongst the main challenges that were encountered while carrying out Post Market Surveillance for Notified Cosmetics are as follows :

a) The advertising of cosmetic products does not require prior approval by the authority, hence errant companies or those that are ignorant towards the guidelines are prone to advertising their products with inaccurate, misleading and unsupported claims.

b) There is still an obvious lack of knowledge and awareness among notification holders on the cosmetic labeling requirements as many of the sampled cosmetic labels were found to be non-compliant.

c) Some notification holders and manufacturers still lack the technical knowledge to conduct safety assessment for cosmetic products as well as cosmetic ingredients.

d) NPCB strives to increase awareness among consumers especially in the area of product safety. This effort is especially important to educate and provide exposure on the safe use of cosmetics because generally, consumers favor products that give quick results without considering its safety.


6. Ilmu pengetahuan, kemahiran dan kepakaran teknikal yang mendalam diperlukan untuk penyelidikan dan perkembangan ujian metodologi bagi perlaksanaan pengujian makmal.

7. Pengujian pengesanan campur palsu dan analog memerlukan pengetahuan, kemahiran dan kepakaran dalam proses pengasingan, pengekstrakan dan purifikasi, Selain itu, ia juga memerlukan pemahaman ‘structural elucidation’ dan kebolehan untuk mentafsir data analitikal.

8. Pengesanan sebatian biomarker untuk verifikasi spesies tumbuhan dalam produk semulajadi memerlukan pengetahuan, kemahiran dan kepakaran dalam proses pengasingan, pengekstrakan dan purifikasi.

9. Clinical Research Malaysia (CRM) merupakan Entry Point Project 2 yang dikenalpasti dalam National Key Economic Area (NKEA). Antara sasaran yang ditetapkan oleh CRM adalah peningkatan bilangan penyelidikan klinikal yang akan dijalankan di Malaysia ke 1000 kajian klinikal menjelang tahun 2020.

Pembinaan satu badan regulatori yang matang, kompetitif dan berpengalaman merupakan salah satu cabaran yang perlu ditangani dalam pengwujudan satu ekosistem yang boleh merangsangkan perkembangan penyelidikan klinikal di Malaysia.

Bagi menangani cabaran ini, pegawai-pegawai penilai dari Pusat Kajian Produk Baru hendaklah diberi latihan spesifik dalam bidang-bidang yang innovatif dan kompleks seperti berikut untuk meningkatkan kemahiran dan kepakaran penilaian pegawai:

a) Penyelidikan klinikal peringkat awal termasuk penyelidikal first-in-human and exploratory clinical trial, dan Advanced Therapy Product termasuk cell-based therapy, tissue engineered product dan gene-therapy medicinal product

b) Kemahiran penilaian seseorang pegawai dalam bidang-bidang tersebut boleh dimantapkan melalui latihan sangkutan dengan badan-badan regulatori yang berpengalaman seperti EMA, USFDA, Australian TGA dan sebagainya. Dengan ini, Malaysia dapat menarik lebih banyak pelaburan dari sponsor untuk menjalankan kajian klinikal di Malaysia di samping merealisasikan sasaran yang ditetapkan oleh CRM.

6. Research and development of testing methodologies in laboratory testing requires knowledge, skills and extensive technical expertise.

7. Detection of adulterants and its analogues requires knowledge, skills and expertise in isolation, extraction and purification processes. Besides, it also requires the understanding of structural elucidation and the capability of interpreting analytical data.

8. Detection of marker compound to verify plant species in natural medicinal products require knowledge, skills and expertise in isolation, extraction and purification processes.

9. Clinical Research Malaysia (CRM) has been identified as Entry Point Project 2 under the Health National Key Economic Areas of the Economic Transformation Programme. Among the goal set by the CRM includes to draw 1,000 clinical trials to be conducted in Malaysia by the year 2020.

Building a mature, competitive and experienced regulatory environment has been identified as one of the issues and challenges that we will need to address in creating a supportive ecosystem to grow clinical research in Malaysia.

In order to build and enhance the ecosystem, evaluators of Centre for Investigational New Product require to undergo specialised training in the following innovative and challenging fields to improve their technical knowledge and efficiency in evaluation clinical trial application:

a) Early phase clinical trial including first-in-human trial and exploratory clinical trial, and Advanced Therapy Product including cell-based therapy, tissue engineered product and gene-therapy medicinal product

b) The manpower capacity building can be achieved via attachment training with other more experienced regulatory authorities, such as European Medicines Agency (EMA), US Food and Drug Administration, Australian Therapeutic Goods Administration and etc. With a more competent regulatory environment, Malaysia can no doubt attract more international clinical trial besides being an important step forward to the realisation of goal set by CRM.



10. Cabaran yang dihadapi oleh Pusat Kajian Produk Baru, BPFK adalah untuk membantu Malaysia mencapai status pematuhan penuh kepada Sistem Mutual Acceptance of Data (MAD) menjelang akhir tahun 2012. Untuk menjadi ahli bukan OECD yang patuh kepada sistem MAD, BPFK telah dinilai oleh pasukan OECD GLP semasa pemeriksaan Mutual Joint Visit (MJV) pada 16 - 18 November 2011 dan laporan mengenai penilahan on-site di Malaysia telah dibentangkan dalam mesyuarat Working Group on GLP ke-26 pada 29 - 31 May 2012. Working Group on GLP telah membuat cadangan kepada Joint Committee untuk menerima Malaysia sebagai ahli bukan OECD yang patuh kepada sistem MAD. Dengan menjadi ahli bukan OECD yang patuh kepada sistem MAD, BPFK akan memastikan Program Pemantauan Pematuhan GLP memenuhi keperluan OECD GLP dan memastikan Fasiliti Kajian di Malaysia mematuhi keperluan GLP.

11. Pada tahun 2012, tiada fi dikenakan ke atas syarikat tempatan untuk pemeriksaan GLP and GCP. BPFK menanggung semua perbelanjaan untuk menjalankan pemeriksaan tersebut. Hal ini telah menjadi suatu beban kewangan terhadap BPFK. Selain itu, komitment yang rendah daripada premis yang diperiksa telah menjadi satu cabaran sebelum, semasa and selepas pemeriksaan. Hal ini adalah ketara terutamanya semasa mereka menjawab corrective actions dan/atau preventive actions untuk penemuan-penemuan pemeriksaan.

12. Mengklasifikasi dan manganalisa laporan-laporan SUSAR berdasarkan system klasifikasi Medical Dictionary for Regulatory Activities (MeDRA) untuk kesan advers .

13. Mewujudkan sistem pengurusan data untuk menganalisa laporan-laporan SUSAR yang diterima untuk pemantauan yang lebih kukuh.

14. Cabaran yang dihadapi dalam aspek pemeriksaan Amalan Pengilangan Baik:

I. Bagi melaksanakan aktiviti pemeriksaan dijalankan dengan penuh integriti dan amanah, pendekatan Good Governance Medicine (GGM) telah mula dipupuk dan diamalkan dalam aktiviti pemeriksaan APB. Pendekatan ini menuntut bilangan minimum pegawai untuk menjalankan pemeriksaan adalah sekurang-kurangnya dua orang bagi setiap pemeriksaan.

10. The challenge for Centre for Investigational New Product is to help Malaysia to achieve the status of full adherence to the Mutual Acceptance of Data (MAD) System by the end of 2012. To become a non-OECD member adhering to MAD system, NPCB had gone through a Mutual Joint Visit (MJV) Inspection by the OECD GLP inspection team on 16th – 18th November 2011 and the report on the on-site evaluation visit to Malaysia was presented at the 26th Meeting of the Working Group on GLP which was held from 29th – 31st May 2012. The Working Group on GLP forwarded the recommendation to Joint Committee before accepting Malaysia as non-OECD member adhering to MAD system. By becoming the non-OECD member adhering to MAD system, NPCB has to ensure its Compliance Monitoring Programme fulfilled the OECD GLP requirements and Test Facilities in Malaysia are in compliance with the requirements of the OECD Principles of GLP.

11. Currently, there is no any charge imposed on the local company for the local GLP or GCP inspection. NPCB has to bear all the costs for carrying out such inspections. This becomes a financial burden on NPCB. Besides that, the poor commitment from some inspected premises was found to be a challenge faced before, during and after the inspection. The lacking of commitment is obvious especially in establishing and implementing corrective actions and/or preventive actions for the inspection findings.

12. To classify and analyse SUSAR reports in accordance to Medical Dictionary for Regulatory Activities (MedDRA) classification for adverse events.

13. Establishing a data management system to analyse the SUSAR reports to facilitate a more robust monitoring system.

14. The challenges faced in Good Manufacturing Practice inspections:

i. In order to perform inspections with integrity and trust, the approach of Good Governance Medicine (GGM) has been adopted and applied in the activities of GMP inspections. This approach requires a minimum number of officers to carry out inspections of at least 2 persons for each inspection.


ii. Sejajar dengan program transformasi negara, bilangan premis pengilang tempatan dijangka akan berkembang dengan pesat terutama yang melibatkan premis bioteknologi meliputi vaksin, terapi sel dan produk darah. Oleh yang demikian, bilangan aktiviti pemeriksaan juga dijangka akan meningkat.

iii. Pengembangan aktiviti pemeriksaan yang melibatkan premis bioteknologi ini memerlukan pegawai-pegawai pemeriksa yang kompeten. Justeru itu, ketersediaan (availablility of) bilangan pegawai pemeriksa yang bertanggungjawab dan kompeten dalam menjalankan pemeriksaan tersebut selaras dengan peningkatan bilangan pemeriksaan yang dikategorikan sebagai berisiko tinggi ini turut menjadi antara cabaran yang perlu dihadapi.

15. Cabaran yang dihadapi dalam aspek pemeriksaan Amalan Pengedaran Baik:

Semua pemegang lesen pemborong dan pengimpot perlu mematuhi keperluan yang terkandung di dalam Garis Panduan AEB. Walaubagaimanapun, masih ada pemegang lesen yang tidak memahami konsep keperluan berkenaan. Oleh itu, sesi dialog dan seminar di antara BPFK dan pihak industri akan terus diadakan untuk penambahbaikan pada masa hadapan. Memandangkan pemeriksaan juga dilaksanakan oleh Cawangan Penguatkuasa Farmasi Negeri, terdapat sedikit perbezaan dari segi praktis ketika pemeriksaan. Bagaimanapun, sesi latihan dan penerangan kepada pegawai daripada Cawangan Penguatkuasa Farmasi akan terus diadakan bagi mengatasi masalah ini.

16. Salah satu cabaran BPFK adalah untuk mendapatkan peruntukan bagi membangunkan Sistem QUEST 3+ yang baru.

ii. In conjunction with the country’s transformation programme, the number of premises for local manufacturers is expected to grow especially in areas of biotechnologies such as vaccine, cell therapy and blood establishments. With that, inspection activities are expected to be on the rise too.

iii. The expansion of inspection activities involving premises that produce biologics requires competent inspectors. Thus, the availability of competent inspectors who are responsible to perform inspections in line with the rising numbers of high risk inspections is among the challenges faced.

15. The challenges faced in the aspect of Good Distribution Practice:

All import and wholesale license holders need to comply with the requirements outlined in GDP guideline. However, there are license holders who are unable to comprehend the related GDP and therefore, dialog sessions and seminars between NPCB and related parties will continue to be held in future for improvements. As the inspection is also conducted by the Pharmacy State Enforcement Division, there are a few differences in practical terms during the inspection. However, continuous training sessions and explanations to the officers from the Pharmacy State Enforcement Division will be held to address this problem.

16. It is a challenge for NPCB to obtain allocations for the development of the new QUEST 3+ System.



HALATUJUTHE WAY FORWARD


HALATUJU THE WAY FORWARD1. Keperluan pendaftaran sentiasa diteliti secara

berterusan supaya selaras dengan keperluan antarabangsa. Pemantauan ini penting supaya produk yang didaftarkan di Malaysia diterima oleh pasaran luar negara kerana produk-produk yang didaftarkan adalah setanding dengan negara-negara lain dari aspek keselamatan, kualiti dan keberkesanan produk.

2. Panduan untuk pendaftaran produk, Drug Registration Guidance Document (DRGD) dikemaskini dengan maklumat yang berkaitan dengan kawalan kualiti, pemeriksaan dan pelesenan. Suatu kajian semula kriteria pengawalseliaan untuk penilaian pendafatarn produk veterinari kategori suplemen kesihatan dan herba akan dijalankan pada tahun 2013. Keperluan pendaftaran perlu selaras dengan Akta Makanan Haiwan 2009 yang akan dikuatkuasakan pada bulan April 2013. Adalah diharapkan dengan hanya satu Agensi kerajaan yang bertanggungjawab untuk mengawal aditif termasuk suplemen kesihatan dan herba ke dalam makanan haiwan akan mewujudkan kawalan ke atas makanan haiwan yang lebih baik.

3. Prosedur untuk mengawal selia API telah dilaksanakan secara berfasa. Pelaksanaan dimulakan secara sukarela dengan penyerahan dokumen API untuk Entiti Kimia Baru pada 1 April 2011 dan diikuti dengan penyerahan wajib pada 1 Januari 2012. Tarikh pelaksanaan penyerahan dokumen API untuk pendaftaran produk generik masih belum ditentukan lagi. Tiada yuran pemprosesan diperlukan bagi permohonan penilaian API kerana ianya merupakan sebahagian daripada permohonan pendaftaran produk.

4. Bermula dari 2013, klasifikasi produk di bawah kategori produk interfasa Makanan-Ubat akan dilakukan oleh BPFK. Keputusan ini diambil untuk membantu industri berurusan dengan hanya satu agensi untuk klasifikasi produk kategori ini.

5. Pelaksanaan keperluan BE akan melibatkan semua formulasi produk generik di samping pelaksanaan awal bagi produk oral, produk immediate release yang mana keperluan BE telah dimulakan untuk permohonan baru pada 1 Januari 2012. Produk berdaftar sedia ada telah diberikan sehingga 1 Januari 2013 utuk mematuhi keperluan ini.

1. The registration requirements are continuously being looked into to be in line with international requirements. This is important as products registered in Malaysia will be able to be marketed overseas as the safety, quality and efficacy of the products are on par with other countries.

2. The Drug Registration Guidance Document (DRGD), which is the reference document for product registration is updated with information pertaining to quality control, inspection and licensing. A review of the regulatory criteria for the evaluation of herbal and health supplement veterinary products will be carried out in 2013. Requirements will have to be streamlined to comply with the Animal Feed Act 2009 to be enforced in April 2013. It is hoped with only one government Agency responsible for the control of additive including health supplements and herbs into animal feed there will be better regulatory control of animal feed.

3. The regulatory control of API has been implemented prospectively according to phases. The implementation has started with voluntary submission of API documents for New Chemical Entities on 1st April 2011 and followed by mandatory submission on 1st January 2012. The implementation date for submission of API documents for registration of generic products will be determined later. No additional processing fee is required as the API application is already incorporated in the product registration application.

4. Starting from 2013, the classification of products under the Food-Drug interphase category will be done by NPCB. This decision was made to help the industry to liaise with only one agency responsible for product classification for this category of products.

5. Implementation of BE requirements for all

formulations of generic products in addition to the earlier implementation for certain oral, immediate-release products commenced for new applications on 1st January 2012. Existing registered products have been given till 1st January 2013 to comply with these requirements.



6. Farmakovigilans sedang melalui tempoh yang memberangsangkan. Selain daripada aktiviti teknikal berkaitan pemantauan kesan advers, kini ia berkembang dengan sasaran untuk mengesan dan mengelakkan kesan advers yang mungkin terjadi, sekaligus mengelakkan penarikan awal ubat yang selamat dan berguna dari pasaran.

i. Memperkukuhkan pengesanan kesan advers ubat

Ini boleh dicapai dengan meningkatkan kualiti pelaporan, melatih pelapor untuk membuat penilaian sebab dan akibat, pelaporan oleh pengguna, mempromosikan pelaporan kesan advers oleh pegamal kesihatan sektor swasta dan penyerahan laporan secara elektronik melalui Pharmacy Information System (PhIS) yang akan mempercepatkan kerja memproses laporan.

Garis panduan untuk melapor dan memantau kesan advers ubat perlu dikemaskini. Selain daripada pemantauan keselamatan yang dijalankan berdasarkan kumpulan farmakologi, pemantauan aktif ke atas isu keselamatan ubat yang spesifik dan pengesanan isu keselamatan yang melibatkan kumpulan spesifik (contohnya warga emas, kanak-kanak dan wanita hamil) perlu dijalankan beserta ujian penjenisan gen.

ii. Memperkukuhkan penilaian isu keselamatan ubatLangkah-langkah yang perlu diambil termasuk memperbaiki sistem pengesanan isyarat, meningkatkan kerjasama antarabangsa dalam penilaian dan pengendalian krisis keselamatan ubat, dan penyepaduan data penggunaan ubat tempatan dengan maklumat farmakovigilans.

iii. Mencegah kesan advers ubat

Ini memerlukan kemudahan akses maklumat ubat yang tepat dan berkecuali pada setiap peringkat perkhidmatan kesihatan. Kesedaran berkenaan keselamatan ubat dan penggunaan ubat secara rasional di kalangan professional kesihatan dan orang awam perlu ditingkatkan. Penyepaduan aktiviti dan prinsip farmakovigilans ke dalam polisi ubat kebangsaan dan amalan klinikal, serta pengawalan dan farmakovigilans ke atas ubat tradisional dan herba yang lebih baik juga dapat membantu mencegah kesan advers ubat.

6. These are exciting times in pharmacovigilance. From being seen as a technical activity concerned with identifying ADRs, it is developing into a broader area with the aim of detecting and preventing potential ADRs while avoiding the premature withdrawal of safe and useful medicines from the market:-

i. Improving detection of ADRs

This is done by improving the quality of reporting, training reporters to perform causality assessment accurately, consumer-reporting, promotion of reporting by private healthcare professionals and electronic submission of reports through the Pharmacy Information System (PhIS) that will expedite the processing of reports.

Guidelines for reporting and monitoring of ADRs have to be updated. Apart from carrying out safety monitoring based on pharmacological group, active surveillance of specific drug safety concerns and detection of safety concerns related to specific populations (for example in the elderly, children and pregnant ladies) should be carried out along with genotyping.

ii. Improving assessment of drug safety issues

Steps that need to be taken are developing an improved signal detection system, increased collaborative links between countries to allow assessment and response to drug safety crises, and integration of local drug usage data with pharmacovigilance information.

iii. Prevention of ADRs

This requires ready access to reliable and unbiased drug information at all levels of healthcare, increased awareness of drug safety and rational drug use among health professionals and the public, integration of pharmacovigilance activities and principles into the national drug policies and clinical practice, and improved regulation and pharmacovigilance of traditional and herbal medicines.


7. Malaysian Variation Guideline (MVG) perlu dibentuk melalui adaptasi ASEAN Variation Guideline dengan mengambil kira keperluan khusus di Malaysia. Kertas cadangan untuk implementasi MVG akan dibentangkan dalam Mesyuarat Dasar Regulatori Farmasi dan Mesyuarat Pihak Berkuasa Kawalan Dadah (PBKD) pada awal tahun 2013. Selain itu, satu latihan kepada pihak industri farmaseutikal mengenai MVG akan diadakan pada tahun hadapan. Ini bertujuan untuk menerangkan dengan lebih terperinci syarat-syarat dan dokumentasi yang diperlukan semasa membuat permohonan variasi kelak.

8. Mesyuarat ACCSQ-PPWG ke-19 menyarankan peneraju utama ASEAN Variation Guideline (AVG) untuk menganjurkan ASEAN Regulators Training. Ini bertujuan untuk meningkatkan pemahaman mengenai AVG.

9. BPFK akan mencadangkan yuran pemprosesan dikenakan bagi permohonan variasi dan pertukaran tapak pengilangan jenis I pada masa akan datang.

10. BPFK merancang untuk mengadakan sesi latihan dan bengkel yang lebih kerap dan terancang kepada industri kecil dan sederhana bagi membimbing dan memberi khidmat nasihat kepada mereka berkenaan pematuhan kepada keperluan notifikasi serta memberikan penekanan terhadap tanggungjawab pihak industri kosmetik.

11. Mengukuhkan aktiviti pemantauan produk kosmetik di pasaran dengan memperluaskan skop dan kriteria produk untuk disampel mengikut corak permintaan pasaran serta memantapkan pemantauan terhadap produk-produk yang diiklankan dengan tuntutan yang melampaui skop takrifan kosmetik.

12. Penambahan skop akreditasi MS ISO/IEC 17025 untuk meliputi:

• Pengesanan dan penentuan Lovastatin dalam produk semulajadi yang mengandungi ‘Red Yeast Rice’

• Pengesanan bahan campur palsu dalam produk semulajadi dan kosmetik

13. Melibatkan diri secara aktif dalam Skim Ujian Profisiensi yang dijalankan oleh WHO dan EC-ASEAN untuk pemantauan prestasi makmal.

14. Meneruskan kerjasama dengan negara-negara ASEAN dalam pengeluaran piawai rujukan ASEAN menerusi kajian bersama.

7. The Malaysian Variation Guideline (MVG) needs to be developed through adaptation of the ASEAN Variation Guideline while taking into account specific requirements in Malaysia. The proposal for implementation of the MVG will be presented at the Pharmacy Regulatory Policy Meeting and DCA meeting in early 2013. Besides that, a training course on MVG for the pharmaceutical industry will be held in 2013. This aims to explain in greater detail the requirements and documentation required for variation applications in the future.

8. The 19th ACCSQ-PPWG meeting urged the leaders of the ASEAN Variation Guideline (AVG) to organise an ASEAN Regulators Training. This aims to increase understanding on the AVG.

9. The NPCB propose to impose processing fee charges for variation and Type I change of manufacturing site in the future.

10. NPCB continuously puts effort in giving training and exposure on the notification requirements to the cosmetic industry especially to the Small Medium Enterprises (SME) by organising workshops, providing consultation and giving emphasis on the responsibilities of the industry.

11. NPCB strives to increase effectiveness of post market surveillance activities for cosmetic by widening sampling criteria according to the emerging market trends as well as strengthening the monitoring and reduction of products that are advertised with overclaims.

12. To expand the accreditation scope of MS ISO/IEC 17025 to include:

• Detection and determination of Lovastatin in natural products containing Red Yeast Rice

• Detection of adulterants in natural and cosmetic products

13. To actively engage in Proficiency Testing Scheme conducted by WHO and EC-ASEAN for laboratory performance monitoring

14. To continue cooperation between ASEAN countries by participation in the ASEAN reference standard production through collaborative studies



15. Melatih lebih banyak pegawai audit makmal kawalan kualiti yang berkelayakan dan kompeten.

16. Meneruskan kerjasama antara negara-negara ASEAN dalam mengharmonisasikan parameter ujian produk semulajadi dan supplemen kesihatan.

17. Meneruskan kerjasama dengan institusi kerajaan yang lain, universiti dan industri produk semulajadi tempatan dalam pembangunan Monograf Herba Malaysia.

18. Menganjur seminar dan sesi latihan untuk industri herba tempatan dari aspek kawalan kualiti produk herba perubatan.

19. Berusaha menerokai bidang ujian analitikal bahan farmaseutikal aktif, vaksin dan produk bioteknologi untuk memastikan keselamatan, kualiti dan efikasi.

20. Membangunkan metodologi untuk pengesanan kompaun penanda dalam spesies tumbuhan yang digunakan dalam produk semulajadi perubatan.

21. Melibatkan diri dalam pembangunan ‘ASEAN Non-Pharmacopoeia Analytical Method under ASEAN Working Group on Pharmaceutical Development (AWGPD)’ yang memberi tumpuan kepada pengesanan bahan campurpalsu farmaseutikal di dalam produk semulajadi.

22. Meneruskan kerjasama antara negara-negara ASEAN di bawah ‘ASEAN Cosmetic Laboratory Committee (ACLC)’ dalam membangunkan dan memperbaiki metodologi ujian untuk produk kosmetik.

23. Bekerjasama dengan institusi kerajaan yang lain dalam bidang penyelidikan bahan toksik dan penanda kompaun negative dalam bahan mentah dan produk herba.

24. Pada masa ini, tempoh sah Lesen Pemborong adalah bermula pada 1 Julai tahun semasa dan luput pada 30 Jun tahun berikutnya. Tempoh ini adalah berlainan daripada tempoh sah Lesen Pengilang dan Lesen Mengimport di mana tempoh sah lesen adalah bermula pada 1 Januari dan luput pada 31 Disember tahun yang sama.

Sehubungan dengan itu, pusat ini akan menyelaraskan tempoh sah Lesen Pemborong kepada Januari-Disember pada tahun yang sama.

15. To train more personnel to become qualified and competent quality control laboratory auditors.

16. To continue cooperation among ASEAN member countries in harmonizing natural product testing parameters (Traditional Medicines and Health Supplement)

17. Continue to participate in the development of Malaysian Herbal Monograph in collaboration with other government institutes, universities and local natural product industries

18. To organize seminars and training session for local herbal industries in the quality control aspect of medicinal herbs and products.

19. To venture in analytical testing of Active Pharmaceutical Ingredients, vaccines and biotechnology products to ensure the safety, quality and efficacy of products.

20. To develop methodologies for detection of marker compound in plant species used in natural medicinal products.

21. To take part in the development of ASEAN Non-Pharmacopeial Analytical Method under ASEAN Working Group on Pharmaceutical Development (AWGPD) focusing on the detection of pharmaceutical adulterants in traditional medicines

22. To continue cooperation among ASEAN member countries under ASEAN Cosmetic Laboratory Committee (ACLC) in developing and improving testing methodologies for cosmetic products

23. To collaborate with other government institutes in the area of research on toxic substances and negative marker compound in herbal raw materials and products.

24. As of now, the validity of Wholesaler’s License starts from 1 July in the current year to 30 June the following year. This validity differs from that of the Manufacturer’s License and Import License where the license validity starts on 1 January and expires on 31 December the same year.

With that, the validity period of Wholesaler’s License will be uniformed that is from January – December the same year.


25. Selain pemeriksaan Amalan Perkilangan Baik (APB) ke atas pengilang tempatan, aktiviti pemeriksaan APB tersebut juga akan diperluaskan ke premis-premis pengilang produk farmaseutikal luar negara. Aktiviti ini dirancang untuk dijalankan secara konsisten di samping mencapai objektif pemeriksaan ke atas pengilang tempatan iaitu pemeriksaan dijalankan dalam tempoh yang ditetapkan bagi premis pengilang keluaran berdaftar dan kosmetik bernotifikasi.

Bagi meningkatkan pengetahuan dan pengalaman pegawai-pegawai pemeriksa dalam aktiviti pemeriksaan terutamanya yang melibatkan premis bioteknologi, Pusat Komplians dan Perlesenan sentiasa mengenalpasti dan merancang siri latihan-latihan APB di dalam dan luar negara yang bersesuaian bagi tujuan tersebut.

26. Pusat Komplians dan Perlesenan bercadang untuk menjadualkan pemeriksaan AEB berdasarkan matriks “risk-based”, di mana senarai pemeriksaan akan dijana berdasarkan kategori produk dan juga risiko produk berkenaan. Pemegang lesen pemborong dan pengimport perlu mengisi Borang Perisytiharan Pematuhan kepada Amalan Pengedaran Baik untuk memastikan mereka mengetahui keperluan yang dinyatakan di dalam Garis Panduan AEB semasa.

27. BPFK akan berusaha untuk mengemaskini Garis Panduan Permohonan Lesen Mengimport Keluaran Tidak Berdaftar untuk Tujuan Percubaan Klinikal (CTIL) dan Kebenaran Mengilang Keluaran Tidak Berdaftar (CTX) di Malaysia edisi kelima mengikut keperluan semasa selaras dengan perubahan keperluan regulatori terkini dan keperluan piaiwaian antarabangsa.

28. BPFK positif dalam memperolehi pematuhan penuh terhadap sistem Mutual Acceptance of Data (MAD) dalam OECD GLP. Sebagai ahli bukan OECD yang patuh kepada system MAD, semua data bukan klinikal yang dihasilkan oleh Fasiliti Kajian komplians GLP di Malaysia akan diterima oleh negara ahli OECD. Hal ini akan memajukan Malaysia sebagai salah satu hub kajian bukan klinikal di Asia Tenggara.

29. Pemeriksaan pusat kajian BE luar negara akan bermula pada tahun 2013. Hal ini adalah selaras dengan pembangunan tabung amanah dan struktur fi untuk pemeriksaan luar negara.

25. Besides local manufacturers, the Good Manufacturing Practice (GMP) inspections will broaden its coverage to overseas pharmaceutical product manufacturers. This activity is planned to be carried out consistently to achieve the objectives of inspections within the stipulated timeframe for local manufacturing premises of registered products and notified cosmetics.

In order to enhance the knowledge and experience

of inspectors in inspection activities especially those involving biotechnology, Centre for Compliance and Licensing continues to identifies and plans a series of GMP training within and outside the country suitable for the purpose.

26. Centre for Compliance and licensing plans to schedule GDP inspections according to ‘risk-based’ matrix, in which the inspection list will be generated based on product category and its related risk. Importer and wholesale license holders have to complete the Declaration of Conformity to Good Distribution Practice to ensure they are aware of the requirements stated in the current GDP guideline.

27. NPCB will update the Guideline for the Application of Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX) in Malaysia, 5th edition to streamline the existing guidelines in accordance with the current needs, regulatory requirements and international standards.

28. NPCB is positive in obtaining full adherence to Mutual Acceptance of Data (MAD) System of OECD GLP. By being a non-OECD member adhering to the MAD, all non-clinical data produced in GLP Compliant Test Facility in Malaysia will be accepted in other member countries. This will enhance Malaysia as one of the non-clinical studies hubs in Southeast Asia.

29. Inspection of overseas BE centres will be initiated in year 2013. This is in line with the establishment of trust fund and fee structure for the overseas inspection.



30. Keperluan untuk melaporkan isu keselamatan berkaitan produk kajian baru di Malaysia telah digabungkan dalam Guidelines for Application of CTIL and CTX in Malaysia, 5th Edition, 2009. Dalam proses penyemakan keperluan tersebut, BPFK telah memutuskan bahawa keperluan tersebut dipisahkan daripada garis panduan tersebut agar suatu garis panduan yang baru dan spesifik mengenai pelaporan isu keselamatan produk kajian baru boleh dibangunkan. Dengan itu, BPFK dapat selalu menyemak and mengemaskini informasi yang terkandung di dalam garis panduan tersebut. Garis panduan yang akan dibangunkan adalah lebih spesifik dan senang difahami oleh industri tempatan. Persetujuan daripada semua pihak berkepentingan akan diperolehi sebelum garis panduan tersebut dikuatkuasakan.

31. BPFK berhasrat untuk mengadakan lebih banyak kerjasama dengan agensi-agensi lain melalui MoU dan mesyuarat teknikal.

32. Memastikan agar sistem baru QUEST 3+ menjadi lebih stabil dan berjalan lancar bagi mengelakkan sebarang gangguan sistem.

33. Mengadakan lebih banyak dialog dan sesi perbincangan bersama pihak industri untuk meningkatkan pematuhan mereka terhadap pelbagai garis panduan dan pekeliling. Langkah ini juga akan membantu dalam mengurangkan jurang antara BPFK dan pihak industri.

30. The Malaysia requirement on safety reporting of investigational new products was incorporated inside the Guidelines for Application of CTIL and CTX in Malaysia, 5th Edition, 2009. In the process of revising the safety reporting requirement, NPCB had decided to separate this requirement from the existing guidelines and establish a new guideline specifically for the safety reporting requirement of investigational new products. By doing so, NPCB could revise or update the guidelines freely and independent from the application of CTIL and CTX in the existing guidelines. The new guideline will be made more specific, easy to understand and useful to the local industry. Consensus will be sought from all stakeholders before the new guideline takes effect in year 2013.

31. NPCB will hope to have more collaboration with other agencies through formal MoUs as well as technical meetings.

32. To ensure that the new QUEST 3+ System will be technically stable and runs smoothly to avoid any interruptions of usage of the system.

33. To hold more dialogues and discussions with the industries to increase their compliance towards various guidelines and circulars. This strategy will also assist in breaking the barrier between NPCB and the industries



AKTIVITI SOSIALSOCIAL ACTIVITIES


Persatuan Suri dan Anggota Wanita Perkhidmatan Awam Malaysia (PUSPANITA)Association of Wives and Ladies of Malaysian Civil Servant (PUSPANITA)

BIL.NO.

TARIKHDATE

AKTIVITIACTIVITIES

31/01/2012 Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 01/2012PUSPANITA NPCB Branch Committee Meeting 01/2012

09/02/2012 Ceramah Sempena Maulidur Rasul 1433 H/2012 oleh Ustaz Zulkifli AhmadTalk on Maulidur Rasul 1433H/2012 by Ustaz Zulkifli Ahmad

20/02/2012Ceramah “Preventing Cancer, Naturally” oleh wakil dari National Cancer Society MalaysiaTalk on “Preventing Cancer, Naturally” by National Cancer Society Malaysia

20/02/2012 Mesyuarat Agung Tahunan PUSPANITA BPFK ke-24NPCB PUSPANITA 24th Annual General Meeting

15/02/2012 Kelas Bacaan Al-Quran Bil 01/2012Al-Quranb recitation class 01/2012

11/05/2012 Ceramah Agama oleh Ustaz Muhammad Bin Abdullah Religious Talk by Ustaz Muhammad Bin Abdullah

22/06/2012 Ceramah “Ibu Bekerjaya dan Penyusuan Susu Ibu”Talk on Breastfeeding for Working Mothers

30/06/2012 Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 02/2012PUSPANITA NPCB Branch Committee Meeting 02/2012

13/07/2012Lawatan Kebajikan sambil Menyumbang ke Asrama Darul Falah (ASDAF), Kuala LumpurCharity Visit & Donation to the Darul Falah Instituition, Kuala Lumpur

16/07/2012 Ceramah agama oleh Ustaz Roslan Bin MohamedReligious Talk by Ustaz Roslan Bin Mohamed

23/07/2012 – 09/08/2012

Tadarus Al-QuranAl-Quran Recitation

10/08/2012 Majlis Khatam Al-Quran PUSPANITA BPFK 1433 H/2012PUSPANITA BPFK 1433 H/2012 Al-Quran Recital

18/10/12 Seminar Penghayatan SolatSeminar on Understanding & Appreciation of Prayers



Badan Kebajikan Kakitangan Islam (BAKKI)Muslim Staff Welfare Association (BAKKI)

BIL.NO.

TARIKHDATE

AKTIVITIACTIVITIES

9/3/2012 Mesyuarat AJK BAKKI bil.01/2012BAKKI Committee Meeting 01/2012

6/4/2012 Majlis Tahlil berikutan pemergian ahli keluarga kakitangan BPFKFuneral Service Prayers following the demise of a family member of NPCB’s staff

12/4/2012 Mesyuarat khas untuk penyemakan semula Perlembagaan BAKKI bil.02/2012Special Meeting on Revsion on the Constitution of BAKKI 02/2012

18/4/2012Ceramah agama bertajuk ‘Konsep Sedekah’ yang disampaikan oleh Ustaz Mat Taib dari Universiti MalayaA religious talk on The Concept of Charity by Ustaz Mat Taib from Universiti Malaya

3/5/2012 Kursus Pengurusan JenazahFuneral Service Course

25/5/2012 Mesyuarat Agung BAKKI bil.02/2012BAKKI Annual General Meeting 02/2012

3/8/2012 Mesyuarat AJK BAKKI bil.3/2012 BAKKI Committee Meeting 03/2012

23/11/2012 Mesyuarat Agung Khas BAKKI ke-33rd BAKKI Annual General Meeting

27/12/2012 Ceramah ‘Bina Hati Cemerlang’ dari pihak YAPEIMTalk on “Bina Hati Cemerlang” from YAPEIM

30/12/2012

Pengumpulan sumbangan dan derma kepada :Collection of funds for donation given to :

• Masjid Bulat Tun Abdul Aziz, Petaling Jaya • Maahad Tahfiz Al-Quran Addin, Ipoh Perak • Asrama Darul Falah, Kuala Lumpur



GALERIGALLERY


Technical Bilateral Meeting between the NPCB and Health Sciences Authority (HSA) Singapore

Technical Bilateral Meeting between the NPCB and the National Agency of Drug and Food Control (NA-DFC), Republic of Indonesia



Workshop on Organisation for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP)


1st Technical Meeting on the Development and Harmonisation of Standards on Pharmaceuticals and Vaccines among OIC Countries



Rural Transformation Centre (RTC) Programme