BAHAGIAN REGULATORI FARMASI NEGARA

BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY

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ISI KANDUNGAN | CONTENT

Visi, Misi, MatlamatVision, Mission, Objective

Perutusan PengarahDirector’s Foreword

Pengurusan TertinggiTop Management

PengenalanIntroduction

Carta OrganisasiOrganisational Chart

Piagam PelangganClient’s Charter

Maklumat Regulatori Terkini Regulatory Updates

Pencapaian NPRANPRA’s achievements

StatistikStatistics

Aktiviti & SorotanHighlights & Activities

Penglibatan & Kolaborasi AntarabangsaInternational Participation & Collaboration

PenerbitanPublications

Laporan Kewangan Financial Report

Halatuju BPFKNPRA’s Way Forward

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BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY2

VISI, MISI, MATLAMATVISION, MISSION, OBJECTIVE

VISIVISION

MISIMISSION

OBJEKTIFOBJECTIVE

• Menjadi badan regulatori bagi ubat-ubatan dan kosmetik yang disegani dunia

• To be an internationally renowned regulatory authority for medicinal products and cosmetics

• Memastikan bahawa bahan-bahan terapeutik yang dibenarkan di pasaran tempatan adalah selamat, berkesan dan bermutu, serta kosmetik yang telah dinotifikasi adalah selamat dan berkualiti

• To 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

• Menjamin kesihatan rakyat melalui kawalan regulatori ubat-ubatan dan kosmetik berlandaskan kecemerlangan saintifik

• To safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics

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Effective medicines regulation promotes and protects public health by ensuring that medicines are safe, efficacious & of quality. NPRA, as the national regulatory agency in Malaysia is responsible for this. Throughout the years, NPRA has taken many steps to strengthen regulatory control in the country.

In 2019, NPRA has conducted a public consultation through an online platform called Unified Public Consultation (UPC) to engage with the public & stakeholders before adding a new requirement for Lot Release Activity for vaccines & blood products. Current practice of lot release requires the applicant to submit the batch release certificate and summary protocol to NPRA before a cold-chain inspection is conducted upon product arrival at the warehouse. Starting from 2020, NPRA will be conducting physical appearance test on each vaccine & plasma product during the Lot Release activity. This physical appearance test is not only a mandatory test conducted by neighboring ASEAN countries but also a recommendation by the World Health Organization. The addition of this test will not affect the current timeline for issuance of Lot Release Certificate and does not involve additional fees.

Peraturan regulatori ubat-ubatan yang berkesan akan meningkatkan dan melindungi kepentingan kesihatan awam dengan memastikan ubat-ubatan yang berada di pasaran adalah selamat, berkesan & berkualiti. NPRA, sebagai badan regulatori kebangsaan di Malaysia bertanggungjawab menjalankan peranan ini. Sejak di peringkat awal penubuhannya lagi, NPRA telah mengambil banyak langkah penambahbaikan untuk memperkasakan kawalan regulatori di negara ini.

Pada 2019, NPRA telah mengadakan konsultasi awam melalui platform atas talian yang dipanggil Unified Public Consultation (UPC) untuk berinteraksi dengan orang ramai & pihak berkepentingan sebelum menambahkan syarat keperluan baru untuk Aktiviti Lot Release bagi vaksin & produk darah. Amalan semasa Lot Release memerlukan pemohon untuk menyerahkan sijil pelepasan kumpulan dan laporan ringkas protokol kepada NPRA sebelum pemeriksaan rantaian sejuk dilakukan semasa ketibaan produk di gudang. Mulai tahun 2020, NPRA akan melakukan ujian penampilan fizikal pada setiap produk vaksin & plasma semasa aktiviti Lot Release. Ujian penampilan fizikal ini bukan hanya ujian wajib yang dilakukan oleh negara-negara anggota ASEAN tetapi juga merupakan saranan Pertubuhan Kesihatan Sedunia (WHO). Penambahan ujian ini tidak akan mempengaruhi tempoh masa bagi pengeluaran Lot Release Certificate dan tidak melibatkan bayaran tambahan.

PERUTUSAN PENGARAHDIRECTOR’S FOREWORD

Datin Dr. Faridah Aryani Md YusofPengarah | Director

Bahagian Regulatori Farmasi Negara | National Pharmaceutical Regulatory Agency


NPRA works very closely with our ASEAN counterparts in medicine regulatory matters through collaborations and workgroups and meet during the ASEAN Meetings twice yearly. This year NPRA had the honor to host two ASEAN level meetings; the 27th ASEAN Consultative Committee for Standards and Quality – Pharmaceutical Product Working Group (ACCSQ-PPWG) Meeting in the beautiful island of Penang and the 32nd ASEAN Consultative Committee for Standards and Quality – Traditional Medicines and Health Supplements Product Working Group (ACCSQ-TMHS) in Petaling Jaya, Selangor. I am truly grateful to be given the confidence to host such events which was a success, not only in terms of technical discussions but as well as fostering the close relationship between the regulators which can be clearly seen during the meetings.

All these will not be possible without the full support from the dedicated staff. I would like to take this opportunity to thank NPRA staff who works tirelessly to ensure all the work processes are carried out smoothly and within the stipulated timeline. I’m very sure with full commitment and cooperation from everyone, NPRA will thrive and reach greater heights in the years to come.

NPRA bekerjasama dengan negara anggota ASEAN dalam hal-hal berkaitan keperluan regulatori farmaseutikal melalui kolaborasi dan aktiviti kumpulan kerja produk yang ditubuhkan di bawah ASEAN Consultative Commitee for Standards and Quality (ACCSQ). Kumpulan-kumpulan kerja ini besidang di mesyuarat peringkat ASEAN dua kali setahun. Pada tahun 2019, NPRA diberi penghormatan untuk menjadi tuan rumah kepada dua mesyuarat ASEAN; iaitu The 27th ASEAN Consultative Committee for Standards and Quality – Pharmaceutical Product Working Group (ACCSQ-PPWG) di Pulau Pinang dan The 32nd ASEAN Consultative Committee for Standards and Quality- Traditional Medicines and Health Supplements Product Working Group (ACCSQ-TMHSPWG) di Petaling Jaya, Selangor. Saya bersyukur kerana Malaysia diberi kepercayaan untuk menjadi tuan rumah dan berasa gembira acara ini berjalan dengan jayanya, bukan sahaja dari segi perbincangan teknikal yang produktif tetapi juga dalam mengeratkan hubungan pelbagai hala antara badan regulatori ASEAN yang jelas terserlah semasa mesyuarat berlangsung

Semua ini tidak dapat dilaksanakan tanpa usaha dan dedikasi dari warga NPRA . Saya ingin mengambil kesempatan ini untuk mengucapkan terima kasih kepada warga NPRA yang sentiasa berusaha memastikan semua proses kerja dapat dijalankan dengan lancar dan diselesaikan dalam tempoh masa yang ditetapkan. Saya amat yakin dengan komitmen dan kerjasama dari semua pihak, NPRA akan maju kehadapan dan mencapai prestasi yang lebih tinggi pada tahun-tahun akan datang.

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PENGURUSAN ATASANTOP MANAGEMENT

Datin Dr. Faridah Aryani Md Yusof

Muhammad Lukmani Ibrahim

Azlin Ahmad

Pengarah Bahagian Regulatori Farmasi Negara

Director National Pharmaceutical Regulatory Agency

Timbalan PengarahPusat Koordinasi & Perancangan Strategik Regulatori

Deputy DirectorCentre of Regulatory Coordination & Strategic Planning

Ketua Pusat Pentadbiran

HeadCentre for Administration

Noorul Akmar Mohd. Nur

Rosilawati Ahmad

Timbalan PengarahPusat Komplians & Kawalan Kualiti

Deputy DirectorCentre of Compliance & Quality Control

Timbalan PengarahPusat Penilaian Produk & Kosmetik

Deputy DirectorCentre of Product & Cosmetic Evaluation


PENGENALANINTRODUCTION

Bahagian Regulatori Farmasi Negara (NPRA) merupakan sebuah badan regulatori kerajaan di bawah Kementerian Kesihatan Malaysia yang bertanggungjawab dalam memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal serta kualiti dan keselamatan produk semulajadi dan kosmetik yang dipasarkan di Malaysia.

NPRA yang dahulunya dikenali sebagai Makmal Pengawalan Farmaseutikal Kebangsaan, telah ditubuhkan pada Oktober 1978. Institusi ini telah ditubuhkan untuk melaksanakan kawalan kualiti ke atas produk farmaseutikal. Infrastruktur dan kemudahan institusi ini direkabentuk bagi memenuhi keperluan aktiviti kawalan dan pengujian kualiti yang dijalankan.

Bermula tahun 1985, NPRA bertanggungjawab untuk memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui penilaian data saintifik dan ujian makmal. Sistem untuk memantau produk-produk di pasaran juga telah diwujudkan. Sejak itu, NPRA telah memperluaskan kawalan kualiti dan keselamatan ke atas produk-produk bukan preskripsi, tradisional, kosmetik, veterinari, bahan aktif farmaseutikal (API) dan seterusnya kawalan ke atas produk vaksin melalui aktiviti Vaccine Lot Release.

Sejajar dengan perkembangan serta keperluan semasa, NPRA telah melaksanakan perubahan struktur organisasi melalui proses pengstrukturan semula yang telah berkuat kuasa mulai 2 Disember 2019. Proses ini melibatkan perubahan utama di mana tujuh pusat asal dalam NPRA telah disusun semula menjadi empat pusat sahaja bagi menyelaraskan semula semua aktiviti utama NPRA mengikut fungsi pusat. Dengan pelaksanaan pengstrukturan semula ini, pihak NPRA akan terus berusaha untuk menambahbaik lagi kualiti perkhidmatan yang diberikan demi mencapai misi untuk menjamin kesihatan rakyat melalui kawalan regulatori ubat-ubatan dan kosmetik berlandaskan kecemerlangan saintifik

National Pharmaceutical Regulatory Agency (NPRA) is a government agency that is responsible in ensuring the quality, safety and efficacy of pharmaceutical products as well as the quality and safety of traditional and cosmetic products marketed in the Malaysia.

NPRA, formerly known as the National Pharmaceutical Control Laboratory, was set up in October 1978. This institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities.

Starting from 1985, NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through evaluation of scientific data and laboratory tests. A system to monitor products in the market was also established. Over the years, NPRA has extended the control of the quality and safety of non-prescription medicines, traditional products, cosmetics, veterinary products, active pharmaceutical ingredients (API) including the quality control of vaccine through Vaccine Lot Release activities.

In line with current developments, NPRA underwent a major restructuring process which came into effect on the 2nd of December 2019, whereby the previous seven centres have been rearranged to four centres, and the main activities of NPRA have been streamlined according to the each centre’s function. Through this restructuring exercise, the NPRA will continuously strive to improve the services provided as we seek to achieve our mission to safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

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Berikut merupakan empat pusat di NPRA dengan tugasan masing-masing :Below are the four centres in NPRA with respective responsibilities :-

• Pengujian makmal bagi semua kategori produkLaboratory testing

• Penilaian data validasiAnalytical validation data evaluation

• Validasi kaedah pengujian baruValidation of new testing methods

• Pemeriksaan ke atas tapak pengilangan produk Inspection on manufacturing sites

• Aktiviti surveilans pasca pendaftaran produkPost registration surveillance activities

• FarmakovigilansPharmacovigilance

• Pemeriksaan ke atas tapak percubaan klinikal Conduct inspections on clinical trial sites

• Pemeriksaan ke atas pusat kajian Bioequivalence Conduct inspections on Bioequivalence centres

• Penilaian ke atas dossier untuk pendaftaran produkDossier evaluation for product registration

• Notifikasi kosmetikCosmetic Notifications

• Penilaian permohonan serta penjanaan lesen import untuk Produk Percubaan Klinikal (CTIL), Kebenaran Mengilang Produk Percubaan Klinikal (CTX) dan Notifikasi Kajian Bioekuivalens (BE)Evaluation and issuance of licences for Clinicial Trial Import License, Clinical Trial Exemption and BE studies notification • Aktiviti pentadbiran dan kewangan

Administrative and financial activities

CARTA ORGANISASIORGANISATIONAL CHART

PENGARAHDIRECTOR

Pusat Komplians dan Kawalan Kualiti Centre of Compliance and Quality Control

Pusat Penilaian Produk dan Kosmetik Centre of Product and Cosmetic Evaluation

Pusat PentadbiranCentre of Administration

• Perancangan halatuju, penyelidikan, pelan strategik dan penambahbaikan aktiviti serta prosedur kerja regulatori.Future, research, strategic planning and improvement activities as well as regulatory work procedures

• Pengendalian dan pemantauan sistem pendaftaran produk dan notifikasi kosmetik atas talian (online), laman web dan mobile apps NPRAHandling & monitoring of the online product registration and cosmetic notification system, website and NPRA mobile apps

• Pengendalian latihan dalam dan luar negara, pengurusan sumber manusia (Pegawai Farmasi), peruntukan dan perkembangan kerjayaHanding local & international trainings, human resource, allocations and career development

• Menyelaraskan sistem pengurusan kualiti jabatan termasuk bagi pensijilan MS ISO 9001Coordinates the quality management system including MS ISO 9001

• Pembangunan Industri & Komunikasi (One Stop Centre) Industry Development & Communication (One Stop Centre)

• Penjanaan lesen dan sijil termasuk Lesen Pengilang, Lesen Memborong, Lesen Mengimport, dan Sijil APBTo generate licenses and certificate including manufacturer’s license, wholesaler’s license, import license and GMP certificate

Pusat Koordinasi & Perancangan Strategik Regulatori

Centre of Regulatory Coordination & Strategic Planning


PENDAFTARAN PRODUK MASA

Penilaian Penuh

• Menilai permohonan pendaftaran:

◦ Ubat preskripsi 210 hari bekerja*

◦ Ubat bukan preskripsi 210 hari bekerja*

◦ Ubat baru dan biologikal 245 hari bekerja*

Penilaian Ringkas

• Menilai permohonan pendaftaran ubat bukan preskripsi#, produk suplemen kesihatan dan produk semulajadi yang mengandungi:

◦ Bahan aktif tunggal 116 hari bekerja*

◦ 2 atau lebih bahan aktif 136 hari bekerja*

• Pengeluaran notifikasi kosmetik 1 hari bekerja^

• Sijil Penjualan Bebas Kosmetik 15 hari bekerja*

• Keputusan permohonan pertukaran pemegang pendaftaran 45 hari bekerja*

• Sijil Produk Farmaseutikal (CPP) / Sijil Penjualan Bebas (CFS) 15 hari bekerja*

• Keputusan permohonan pertukaran tapak pengilang 60 hari bekerja*

PELESENAN MASA

• Pengeluaran lesen pengilang, pemborong dan mengimport 4 hari bekerja*

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

◦ Bagi produk yang melibatkan Kajian Fasa 1, produk biologikal, Cell & Gene Therapy Products (CGTPs) dan produk herba

45 hari bekerja*

◦ Bagi produk-produk selain daripada yang disebutkan di atas 30 hari bekerja*

* Setelah permohonan lengkap diterima^ Bagi permohonan yang memenuhi keperluan yang ditetapkan # Bagi produk-produk yang disenaraikan pada Table V Drug Registration Guidance Document (DRGD)

PIAGAM PELANGGANCLIENT CHARTER

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PRODUCT REGISTRATION DURATION

Full Evaluation

• To evaluate application for registration of:

◦ Prescription drugs 210 working days*

◦ Non-prescription drugs 210 working days*

◦ New drugs and biological 245 working days*

Abridged Evaluation

• To evalute application for registration of non-prescription medicine#, health supplements and traditional products containing:

◦ Single active ingredient 116 working days*

◦ 2 or more active ingredients 136 working days*

• Issuance of cosmetic notification 1 working day^

• Certificate of Free Sale for Cosmetic Products 15 working days*

• Change of registration holder 45 working days*

• Certificate of Pharmaceutical Product (CPP) / Certificate of Free Sale (CFS) 15 working days*

• Change of manufacturing site application 60 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):

◦ For products involving Phase 1 Trial, biological products, Cell & Gene Therapy Products (CGTPs) and herbal products

45 working days*

◦ For products other than stated above 30 working days*

* Upon receipt of complete application^ For applications fulfilling the stipulated requirements# For products that are listed in Table V of the Drug Registration Guidance Document (DRGD)


MAKLUMAT REGULATORI TERKINI

REGULATORY UPDATES

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Facilitated Registration Pathway

Full Dossier + Reference agency assessment report

Full Dossier + Reference agency assessment report

Approved by one reference agency

Approved by two reference agencies

Full evaluation: quality Abridge evaluation:

clinicalReference agency assessment report

Timeline 120 w.d.Timeline 90 w.d.

Approved by at least one regulatory agency

Full evaluation: quality, non-clinical & clinical

Timeline 245 w.d.

Full Dossier

NormalRegistration Pathway

FacilitatedRegistration Pathway:

ABBREVIATED REVIEW

FacilitatedRegistration Pathway:

VERIFICATION


Keperihatinan yang semakin meningkat kepada keperluan badan regulatori untuk bekerjasama telah membawa kepada kemunculan model kerjasama yang baru. Pertubuhan Kesihatan Sedunia (WHO) mencadangkan satu skim bagi Badan Regulatori Kebangsaan (NRA) di mana pendaftaran dan kelulusan ubat-ubatan yang telah diluluskan oleh NRA rujukan dipercepatkan.

NPRA telah mula melaksanakan praktis ini melalui satu sistem yang dipanggil Facilitated Registration Pathway (FRP) sejak 1 April 2019. Objektif FRP adalah untuk memastikan capaian ubat-ubatan inovatif oleh pesakit yang memerlukannya dalam masa yang cepat serta mengurangkan pertindihan kerja, terutamanya bagi produk di mana keselamatan dan keberkesanannya telah disahkan oleh Stringent Regulatory Authorities. FRP hanya boleh digunapakai untuk produk ubat baru (NCE) dan produk biologik (termasuk biosimilars).

Terdapat dua laluan dalam FRP iaitu: -

I. Verification Review untuk produk yang telah dinilai dan diluluskan oleh sekurang-kurangnya dua (2) Badan Regulatori Kebangsaan*

II. Abbreviated Review untuk produk yang telah dinilai dan diluluskan oleh sekurang-kurangnya satu (1) Pihak Berkuasa Regulatori Kebangsaan*

[*Badan Regulatori Kebangsaan yang dirujuk adalah European Medicines Agency (EMA) and United States Food & Drug Administration (US FDA)]

Maklumat terperinci mengenai FRP boleh didapati dalam Guideline on Facilitated Registration Pathway: Abbreviated and Verification yang bertarikh Mac 2019 yang terdapat di laman sesawang NPRA.

The growing awareness of the need for regulators to work together has led to the emergence of new models of cooperation. World Health Organization (WHO) proposes a scheme for National Regulatory Authorities (NRA) in which registration and approval of medicines already approved by reference NRAs are facilitated.

NPRA has started implementing this practice through a system called Facilitated Registration Pathway (FRP) since 1st April 2019. The objective of FRP is to ensure innovative medicines can be accessible to patients in need in a timely manner as well as to reduce duplication, especially for products where safety and efficacy have already been confirmed by Stringent Regulatory Authorities. The FRP only applies to new chemical entity (NCE) and biologics (including biosimilars).

There are two pathways in FRP which are :-

I. Verification Review applies to a product that has been evaluated and approved by at least two (2) reference drug regulatory agencies*

II. Abbreviated Review applies to a product that has been evaluated and approved by at least one (1) reference drug regulatory agency*

[*Reference drug regulatory agencies are European Medicines Agency (EMA) and United States Food & Drug Administration (US FDA)]

In depth information on FRP can be found in the Guideline on Facilitated Registration Pathway: Abbreviated and Verification Review dated March 2019 which is available on NPRA’s website.

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PENCAPAIAN

ACHIEVEMENTS


NPRA telah mendapat pengiktirafan antarabangsa sebagai WHO Collaborating Centre for Regulatory Control of Pharmaceuticals pada tahun 1996. Pengiktirafan ini telah diberi oleh Pertubuhan Kesihatan Dunia (WHO) atas sumbangan NPRA dalam bidang regulatori farmasi.

Melalui NPRA, Malaysia juga merupakan negara anggota Pharmaceutical Inspection Co-operation Scheme (PIC/S) sejak Januari 2002. Sejak itu, NPRA terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan Quality Assurance Programme. Tujuan PIC/S ini adalah untuk membantu jaringan kerjasama di antara badan regulatori negara-negara ahli di dalam pertukaran maklumat dan pengalaman di dalam bidang APB serta latihan pemeriksa APB.

Melalui NPRA, Malaysia telah diterima sebagai ahli penuh Organisation for Economic Cooperation and Development Good Laboratory Practice Mutual Acceptance of Data System (OECD MAD) mulai 29 Mac 2013. Data bukan klinikal yang dijalankan di bawah Program Pemantauan Komplians GLP NPRA akan diterima oleh semua negara OECD dan bukan OECD yang mematuhi system MAD.

Malaysia juga telah diterima sebagai pemerhati kepada International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) sejak Jun 2018. ICH merupakan platform untuk pihak regulatori dan industri farmaseutikal membincangkan aspek saintifik dan teknikal pendaftaran ubat-ubatan. Misi ICH adalah untuk mencapai harmonisasi secara menyeluruh bagi memastikan ubat-ubatan yang selamat, berkesan, dan berkualiti tinggi dapat didaftarkan dengan cara yang paling efisien. Sebagai pemerhati, Malaysia akan dapat memastikan bahawa standard kawalan regulatori farmaseutikal yang digunapakai di negara ini adalah setanding dengan piawaian antarabangsa. Malaysia juga layak untuk melantik seorang pegawai untuk menjadi sebahagian daripada Kumpulan Kerja Pakar dalam merangka garis panduan keperluan teknikal untuk penilaian produk farmaseutikal yang berkaitan.

NPRA has been given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization for NPRA’s contribution in the field of regulatory affairs.

Malaysia (through NPRA is also a Member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 1st January 2002. Since then, NPRA has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance Programme. The purpose of PIC/S is to facilitate the networking between participating authorities in the exchange of information and experience in the field of GMP and related areas and training of GMP inspectors.

Through NPRA, Malaysia has been accepted as a full adherent member to Organisation for Economic Cooperation and Development Good Laboratory Practice Mutual Acceptance of Data System (OECD MAD) for Good Laboratory Practice (GLP) starting 29 March 2013. The non-clinical data conducted under the NPRA Compliance Monitoring Programme shall be accepted by all OECD countries and non-OECD countries that adhere to the MAD System.

Malaysia has been accepted to become an observer to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use since June 2008. ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. As an observer, Malaysia will be able to ensure that the standard of pharmaceutical regulatory control practiced in this country is equivalent to internationally standards. Malaysia is also eligible to appoint a relevant officer to be part of the Expert Working Group in drafting the technical requirement guideline for the evaluation of relevant pharmaceutical products.

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In order to ensure high quality and efficient service, NPRA has obtained the MS ISO 9001 certification from SIRIM QAS Sdn. Bhd. NPRA has successfully maintained the MS ISO certification for 19 consecutive years (2001 - 2019) starting with version MS ISO 9002: 1994, followed by the MS ISO 9001: 2000, MS ISO 9001: 2008 and most recently with the certification of version MS ISO 9001:2015 in 2017 with certificate number QMS 00894 which is valid until 24th May 2022.

In addition to MS ISO 9001 certification, NPRA laboratories are accredited by the Department of Standard Malaysia for their competence and ability to operate in accordance with MS ISO / IEC 17025. NPRA has successfully maintained MS ISO / IEC 17025: 2005 accreditation for the past 10 years (2010 - 2019) in the scope of chemical and microbiological testing with accreditation number No. SAMM 450 which is valid until 30th November 2020.

Bagi memaparkan perkhidmatan yang berkesan dan berkualiti, NPRA telah memperolehi pensijilan MS ISO 9001 dari pihak SIRIM QAS Sdn. Bhd. NPRA telah berjaya mengekalkan pensijilan MS ISO selama 19 tahun berturut-turut (2001 - 2019) bermula dari versi MS ISO 9002:1994, diikuti dengan versi MS ISO 9001:2000, MS ISO 9001:2008 dan terkini dengan pensijilan versi MS ISO 9001:2015 pada tahun 2017 dengan nombor sijil adalah QMS 00894 dan sah sehingga 24 Mei 2022.

Selain pensijilan MS ISO 9001, makmal-makmal di NPRA diakreditasi oleh Jabatan Standard Malaysia kerana mempunyai kompetensi untuk beroperasi selaras dengan MS ISO/IEC 17025. NPRA telah berjaya mengekalkan akreditasi MS ISO/IEC 17025:2005 selama 10 tahun berturut-turut (2010 - 2019) dalam skop pengujian kimia dan mikrobiologi dengan nombor akreditasi No. SAMM 450 yang sah sehingga 30 November 2020.

World Health Organization

Pharmaceutical InspectionCo-operation Scheme

Organisation for Economic Cooperation and Development

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use


NPRA sentiasa mempromosikan Amalan Regulatori Baik (GRP) dalam pembangunan dasar dan garis panduan baru selaras dengan penglibatan kerjasama antarabangsa melalui platform OECD-GLP-MAD, PIC/S dan kumpulan kerja ASEAN. NPRA telah diberi sijil penghargaan atas sumbangan aktif dan komitmen yang diberikan terhadap pelaksanaan Dasar Negara Bagi Pembangunan dan Pelaksanaan Peraturan (NPDIR) selama dua tahun berturut-turut (tahun 2018 dan 2019) di Konvensyen Kebangsaan Amalan Regulatori Baik yang telah dianjurkan oleh Malaysian Productivity Corporation (MPC). Anugerah ini bertujuan untuk memupuk kepentingan pelaksanaan GRP khususnya bagi perancangan dasar, terutamanya dalam memastikan dasar dan peraturan kerajaan adalah berkualiti serta dapat meningkatkan pertumbuhan ekonomi dan produktiviti di Malaysia.

Imej 1 : Pengarah NPRA, Datin Dr. Faridah Aryani (empat dari kiri) menerima sijil bagi pihak NPRA

NPRA is promoting Good Regulatory Practices (GRP) in approaching new policies and guidelines that are in line with the international consensus from the OECD-GLP-MAD, PIC/S and ASEAN TWG committee platforms. NPRA received a certificate of recognition for its active contribution and high commitment to the implementation of National Policies for the Development and Implementation of Regulations for two years in row (2018 and 2019) in the National Convention on Good Regulatory Practice (GRP) program organized by the Malaysian Productivity Corporation. The award was given to continuously foster the importance of the GRP for the policy makers especially in ensuring the quality of government policies and regulations for a higher economic growth and productivity in Malaysia.

PENGIKTIRAFAN KEPADA NPRA DALAM PERLAKSANAAN DASAR NEGARA BAGI PEMBANGUNAN DAN PERLAKSANAAN PERATURAN (NPDIR)RECOGNITION TO THE NPRA FOR THE IMPLEMENTATION OF THE NATIONAL POLICY FOR DEVELOPMENT AND IMPLEMENTATION OF REGULATIONS (NPDIR)

Image 1 : Director of NPRA, Datin Dr. Faridah Aryani (fourth from the left) accepting the certificate on behalf of NPRA

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PEMBANGUNAN MONOGRAF HERBA MALAYSIADEVELOPMENT OF THE MALAYSIAN HERBAL MONOGRAPH

Pembangunan Monograf Herba Malaysia (MHM) adalah projek progresif yang melibatkan pelbagai agensi dan kementerian dari Bahagian Industri Tanaman, Ternakan dan Perikanan Kementerian Pertanian dan Industri Asas Tani, Institut Penyelidikan Perubatan (IMR), Bahagian Regulatori Farmasi Negara (NPRA), Institut Penyelidikan Perhutanan Malaysia (FRIM), Institut Penyelidikan dan Kemajuan Pertanian Malaysia (MARDI), dan institusi pengajian tinggi tempatan seperti Universiti Putra Malaysia (UPM), Universiti Kebangsaan Malaysia (UKM) dan Universiti Sains Malaysia (USM).

Inisiatif pembangunan MHM adalah bertujuan untuk menyediakan rujukan maklumat yang menyeluruh dan komprehensif tentang identifikasi spesies herba, keperluan kawalan kualiti, kegunaan dari segi perubatan tradisional dan data keselamatan untuk herba tempatan yang bernilai tinggi. Oleh itu, MHM adalah wahana yang amat berguna khususnya untuk industri ubat tradisional, agensi regulatori, para penyelidik dan orang awam amnya.

Peranan NPRA dalam pembangunan Monograf Herba Malaysia adalah termasuk:

a) Pengerusi bersama bagi Jawatankuasa Induk dan Jawatankuasa Teknikal MHM

b) Menjalankan ujian verifikasi bagi data yang diperoleh daripada institusi pembangunan monograf

c) Menyokong aktiviti Sekretariat MHM yang diketuai oleh IMR (Menjalankan latihan untuk industri tradisional tempatan dan juga untuk jawatankuasa MHM).

Sejumlah dua monograf diterbitkan pada tahun 2019 iaitu Belimbing Buluh (Averrhoa Bilimbi) dan Serai Wangi (Cymbopogon Nardus). Dari 2011 hingga 2019, sebanyak 76 monograf telah diterbitkan dan dimuat naik di laman web Global Information Hub on Integrated Medicine (GlobinMed).

The Malaysia Herbal Monograph (MHM) development is a progressive project carried out by various agencies and ministries including Ministry of Agriculture and Agro-based Industry, Institute of Medical Research (IMR), National Pharmaceutical Regulatory Agency (NPRA), Forest Research Institute Malaysia (FRIM), Malaysian Agricultural Research and Development Institute (MARDI) and academia such as Universiti Putra Malaysia (UPM), Universiti Kebangsaan Malaysia (UKM) and Universiti Sains Malaysia (USM).

MHM serves as a crucial reference that provides invaluable, comprehensive information regarding identification of herbs, quality control requirements, medicinal usage and safety information for high value local herbal plants, which are extremely useful for the traditional medicines industry, regulatory agencies, researchers and general public.

The roles of NPRA, Ministry of Health (MOH) Malaysia in the development of the Malaysian Herbal Monograph include:

a) Co-chair the MHM Main Committee and MHM Technical Committee

b) To verify testing methods and data obtained by the developer of the monograph

c) To support the MHM Secretariat activities led by IMR (Conduct training for the local traditional industry as well as for the MHM committee).

A total of 2 monographs were published in 2019 namely Belimbing Buluh (Averrhoa Bilimbi) and Serai Wangi (Cymbopogon Nardus). From 2011 until 2019, 76 monographs have been published and uploaded on Global Information Hub on Integrated Medicine (GlobinMed) website.


Imej 2 : Sebahagian daripada Monograf Herba Malaysia

Image 2 : A portion of the Malaysian Herbal Mohograph

Dukung anak (aerial)Phyllantus urinaria

(UKM)

Kulat susu rimau (sclerotium) Lignosus

rhinocerus (NPRA)

Kayu manis (daun)Cinnamomum verum

(USM)

Serai wangiCymbopogon Nardus

(USM)

Kucing galak (aerial)Phyllantus urinaria

(UKM)

Urang-aring (daun)Eclipta prostrata

(MARDI)

Belimbing buluhAverrhoa Bilimbi

(UPM)

Dukung anak (aerial)Phyllantus amarus

(UKM)

Manggis (kulit)Garcinia mangostana

(UPM)

19

STATISTIK

STATISTICS


A) PENDAFTARAN PRODUKA) PRODUCT REGISTRATION

NPRA bertanggungjawab untuk memproses permohonan pendaftaran untuk produk entiti kimia baru / ubat-ubatan baru, biologik, preskripsi, bukan preskripsi, supplemen kesihatan, produk tradisional dan juga veterinar.

Sepanjang 2019, sebanyak 1,324 produk telah didaftarkan daripada 1,557 permohonan yang diterima. Produk-produk ini terdiri daripada 49.26 peratus produk tempatan dan 50.74 peratus produk yang diimport. Kumulatif produk yang masih berdaftar sehingga Disember 2019 adalah 23,655 produk

NPRA is responsible for processing registration applications for new chemical entities / new drugs, biologics, prescription, non-prescription, health supplements, traditional as well as veterinary products.

Throughout 2019, a total of 1,324 products were registered out of 1,557 applications received. These products comprises of 49.26 percent local products and 50.74 percent imported products. The cumulative number of registered products up to December 2019 is 23,655 products.

Jadual 1 : Bilangan Produk Yang Didaftarkan 2015-2019

Kategori Produk2015 2016 2017 2018 2019

Product Category

Produk Preskripsi280 263 325 354 187

Prescription Products

Produk Bukan Preskripsi41 40 61 79 66

Non-Prescription Products

Produk Tradisional569 648 651 738 679

Traditional Products

Supplemen Kesihatan236 238 242 322 315

Health Supplements

Produk Veterinar94 79 68 73 77

Veterinary Products

Jumlah1,220 1,268 1,347 1,566 1,324

Total

Table 1 : Number of Registered Products, 2015-2019

21

B) AKTIVITI PASCA PENDAFTARAN PRODUKB) PRODUCT POST-REGISTRATION ACTIVITIES

NPRA menjalankan pemantauan secara berterusan ke atas produk berdaftar di pasaran tempatan bagi memastikan produk tersebut menepati keperluan keselamatan, keberkesanan dan kualiti. Pada tahun 2019, Program Pemantauan Kesan Advers Ubat (ADR) Kebangsaan telah menerima sebanyak 29,983 laporan, peningkatan 14.8% berbanding tahun sebelumnya.

NPRA continuously monitors registered products in the local market to ensure that the products adhere to safety, efficacy and quality requirements. In 2019, the National Adverse Drug Reactions (ADR) Monitoring Program received a total of 29,983 reports, an increase of 14.8% compared to the previous year.

Kategori ProdukProduct Category

2015 2016 2017 2018 2019

Produk FarmaseutikalPharmaceutical Products

793 613 838 991 893

Produk TMHSTMHS Products

18 6 3 22 236

JumlahTotal

811 619 841 1,013 1,129

2015

13675 13789

15936

26110

29983

2016 2017

Tahun / Year

Rajah 1 : Bilangan Laporan ADR yang Diterima, 2015-2019 Figure 1: Number of ADR Reports Received, 2015-2019

Jadual 2 : Bilangan Aduan Produk Berdaftar yang Diterima, 2015-2019Table 2: Number of Registered Product Complaints Received, 2015-2019

2018 2019


C) AKTIVITI KOMPLIANS DAN PELESENANC) COMPLIANCE AND LICENSING ACTIVITIES

Pemeriksaan Amalan Perkilangan Baik (APB) ke atas pengilang produk berdaftar dan kosmetik bertujuan memastikan pematuhan mereka terhadap keperluan APB manakala Pemeriksaan Amalan Pengedaran Baik (AEB) bagi memastikan pematuhan pengimport dan pemborong terhadap keperluan AEB semasa. Sepanjang tahun 2019, sebanyak 385 pemeriksaan APB dan 179 pemeriksaan AEB telah dijalankan. Selain itu, perkhidmatan melibatkan khidmat nasihat dan penilaian pelan susun atur premis juga disediakan untuk pengilang.

Good Manufacturing Practice (GMP) inspections on the manufacturer of registered products and notified cosmetics are carried out to ensure their compliance with the current GMP requirements while Good Distribution Practice (GDP) inspections ensure adherence of importers and wholesalers to the current GDP requirements. There were 385 GMP inspections and 179 GDP inspections conducted in the year 2019. Additional services such as technical guidance and premise plan layout reviews were also provided to manufacturers.

Aktiviti Activity

2015 2016 2017 2018 2019

Pemeriksaan APB GMP Inspections

350 470 433 440 385

Pemeriksaan AEB GDP Inspections

124 221 154 192 179

Semakan Pelan Premis Premise Plan Review

63 84 106 127 99

Panduan Teknikal Technical Guidance

200 86 113 51 39

Jadual 3: Bilangan Pemeriksaan Premis, Semakan Pelan Premis serta Panduan Teknikal yang Dijalankan, 2015-2019

Table 3: Number of GMP Inspections, Premise Plan Review and Technical Guidance, 2015-2019

23

In 2019, 543 Manufacturer Licenses, 919 Importer Licenses and 1,302 Wholesaler Licenses were issued.

2015 2016 2017 2018 2019

266 200 304 483 543

455 430 464 799 919

1164 1203 1110 1613 1302

Rajah 2 : Bilangan Lesen yang Dikeluarkan, 2015-2019Figure 2 : Number of License Issued, 2015-2019

2015 2016 2017 2018 2019

266200

304

483543

455 430 464

799919

1164 12031203

1613

1302

Tahun / Year

PengilangManufacturer

PengimportImporter

PemborongWholesaler

Pada tahun 2019, sebanyak 543 Lesen Pengilang, 919 Lesen Pengimport dan 1,302 Lesen Pemborong telah dikeluarkan.


D) PENGUJIAN MAKMALD) LABORATORY TESTING

Pengujian sampel ke atas produk farmaseutikal, produk semulajadi serta kosmetik dijalankan mengikut standard regulatori global. Tugas-tugas ini dijalankan oleh kakitangan makmal yang cekap dan terlatih.

Pengujian produk dijalankan untuk tujuan pendaftaran bagi produk semulajadi, untuk tujuan pengawasan bagi produk berdaftar dan kosmetik bernotifikasi, sampel yang menyebabkan kesan advers (ADR) serta sampel aduan dan sampel penguatkuasaan.

Sampel testing is carried out on pharmaceutical products, traditional products and cosmetics in accordance with global regulatory standard. These duties are carried out by trained and competent laboratory personnel.

Product testing is carried out for the purpose of registration for traditional products, for the purpose of surveillance for registered products and notified cosmetic products, samples with adverse drug reactions (ADR) as well as complaint and enforcement samples.

Rajah 3 : Sampel Yang Diuji Mengikut Kategori Untuk Tahun 2019Figure 3 : Samples Tested Based on Category For Year 2019

660

0 9 0 1037

282

0 11 0 0 0

164

0 0 8 0 0

816

039

0 9 0

903

650

5 5

67

0Pendaftaran/ Registration

Pengawasan/ Surveillance

Aduan/ Complaint

ADRCPF/

EnforcementLain-lain/

Others

PreskripsiPrescription

Bukan PreskripsiNon Prescription

SemulajadiNatural Products

Suplemen KesihatanHealth Supplements

KosmetikCosmetics

25

Pada tahun 2019, pecahan sampel mengikut kategori produk digambarkan dalam carta di atas. Sampel Pengawasan mencatatkan bilangan sampel diuji tertinggi iaitu berjumlah 2,825 sampel dengan bilangan sampel tertinggi untuk kategori produk semulajadi iaitu sebanyak 903 sampel.

Untuk tahun 2019, pengujian makmal telah dijalankan ke atas 3,675 sampel yang merupakan bilangan tertinggi dicatatkan sejak tahun 2015. Bilangan sampel yang gagal pengujian ialah 269 sampel sahaja iaitu 7.3% daripada jumlah sampel yang diuji.

Bilangan ujian juga didapati meningkat pada tahun 2019 iaitu berjumlah 64,839 ujian selaras dengan pertambahan bilangan sampel yang diuji.

In the year 2019, the breakup of samples tested according to categories are depicted in the chart above. Surveillance samples recorded the highest number of samples at a total of 2,825 with the highest number of samples coming from the natural products category at 903 samples.

For the year 2019, laboratory testing has been conducted on 3,675 samples which is the highest number recorded since 2015. The number of samples which failed testing amounted to 269 samples only, equivalent to 7.3% of the total number of samples tested.

The number of tests also showed an increase in the year 2019 at a total of 64,839 tests in accordance with the increase in the number of samples tested.

Rajah 4 : Bilangan Sampel Diuji dan Bilangan Sampel Gagal Pengujian, 2015-2019Figure 4 : Number of Sample Tested & Number of Failed Samples, 2015-2019

Bilangan sampel diujiNumber of samples tested

Bilangan sampel gagal pengujianNumber of failed samples

263 326227

320 269

3216

3567

3317

35663675

2015 2016 2017 2018 2019

Tahun / Year


Bilangan ujian juga didapati meningkat pada tahun 2019 iaitu berjumlah 64,839 ujian selaras dengan pertambahan bilangan sampel yang diuji.

The number of tests also showed an increase in the year 2019 at a total of 64,839 tests in accordance with the increase in the number of samples tested.

Rajah 5 : Bilangan Ujian yang Dijalankan, 2015-2019Figure 5 : Number of Test Performed, 2015-2019

48,528 48,14152,129

58,023

64,839

20162015 2017 2018 2019

Tahun / Year

Bilangan ujianNumber of tests

27

Apart from the routine analytical tests conducted on samples to assess the products’ quality, detection of adulterants is among the failure reasons. For 2019, 84 out of 1,294 samples of natural products tested have been found to be adulterated.

Selain daripada ujian-ujian analisis rutin yang dijalankan ke atas sampel untuk menilai kualiti produk berkenaan, antara ujian makmal yang gagal ialah pengesanan bahan campur palsu dalam produk semulajadi. Untuk tahun 2019, 84 daripada 1,294 sampel produk semulajadi telah dikesan mengandungi bahan campur palsu.

Rajah 6 : Bilangan Produk Semulajadi yang Dikesan Mengandungi Bahan Campur PalsuFigure 6 : Number of Natural Products detected with adulterants

20162015 2017 2018 2019

Tahun / Year

863

1,250

1,1411,191

1,294

104181

74142

84

Bilangan sampel diujiNumber of samples tested

Bilangan sampel dikesan bahan campur palsuNumber of samples detected with adulterants


AKTIVITI & SOROTAN

HIGHLIGHTS & ACTIVITIES

29

MESYUARAT ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - PHARMACEUTICAL PRODUCT WORKING GROUP (ACCSQ- PPWG) YANG KE-27THE 27TH ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - PHARMACEUTICAL PRODUCT WORKING GROUP (27TH ACCSQ- PPWG)

Malaysia, melalui NPRA giat mengambil bahagian dalam mesyuarat-mesyuarat kumpulan kerja ASEAN. Setiap negara anggota ASEAN akan bergilir-gilir untuk menganjurkan mesyuarat ini yang diadakan dua kali setahun.

NPRA telah diberi penghormatan untuk menjadi tuan rumah bagi mesyuarat ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group yang ke-27. Mesyuarat ini telah diadakan di Hotel G Gurney, Pulau Pinang bermula 24 sehingga 27 Jun 2019. Lebih 250 peserta, termasuk pegawai agensi regulatori ubat-ubatan serta pihak industri farmaseutikal daripada negara anggota ASEAN telah menghadiri program yang berlangsung selama 4 hari ini. Sidang mesyuarat ini telah dirasmikan pada 25 Jun 2019 oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal.

Objektif utama mesyuarat ACCSQ-PPWG adalah untuk mewujudkan harmonisasi dalam skim peraturan produk farmaseutikal yang dapat digunapakai oleh negara anggota ASEAN, serta turut membantu mencapai objektif ASEAN Free Trade Area (AFTA) iaitu mengurangkan halangan teknikal sedia ada tanpa menjejaskan kualiti, keselamatan dan efikasi produk tersebut.

Through the NPRA, Malaysia has always actively participated in the ASEAN product working group meetings. Each ASEAN member state will take turn to host these meetings which convene twice a year.

This time, NPRA hosted the 27th ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group (ACCSQ - PPWG) Meeting. The meeting was held at G Hotel Gurney, Penang from 24th to 27th June 2019. Over 250 participants, including regulators as well as members of the pharmaceutical industry from the ASEAN member states attended this 4-day program. The meeting was formally officiated on 25th June 2019 by the Senior Director of Pharmaceutical Services Programme, Dr Ramli Zainal.

The main objectives of the ACCSQ-PPWG meeting are to develop a harmonization scheme of pharmaceutical regulations to be commonly implemented by the ASEAN member states, to facilitate the objective of ASEAN Free Trade Area (AFTA) which is to elimination of technical barriers to trade that are posed by these regulations without compromising on drug quality, safety and efficacy.


Imej 3 : Mesyuarat ACCSQ-PPWG ke-27 telah dirasmikan oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal

Imej 4 : The Heads of Delegates from the ASEAN member states

Image 3 : The 27th ACCSQ-PPWG Meeting was officiated by the Senior Director of Pharmaceutical Services Programme, Dr. Ramli Zainal

Image 4 : Ketua Perwakilan daripada negara anggota ASEAN

31

Imej 5 : Delegasi Malaysia (Kiri-kanan : Datin Dr. Faridah Aryani Md Yusof, Pn. Noraisyah Mohd Sani, Pn. Jenny Thong Che Ni)

Imej 6 : Sesi Mesyuarat ACCSQ-PPWG ke-27

Image 5 : Malaysian Delegation (Left-right : Datin Dr. Faridah Aryani Md Yusof, Pn. Noraisyah Mohd Sani, Pn. Jenny Thong Che Ni)

Image 6 : The 27th ACCSQ-PPWG Meeting in session


Selain daripada menganjurkan Mesyuarat ACCSQ-PPWG ke-27 pada Jun 2019, NPRA juga telah menganjurkan Mesyuarat ACCSQ-TMHS PWG yang bertempat di Royale Chulan Damansara Hotel, Selangor daripada 4 hingga 8 November 2019.

Pegawai kerajaan daripada badan regulatori dan ahli industri TMHS dari negara anggota ASEAN telah menghadiri program yang berlangsung selama 5 hari ini. Jumlah peserta bagi mesyuarat ini adalah sebanyak 118 orang. Sidang mesyuarat ini telah dirasmikan pada 25 Jun 2019 oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal.

Objektif utama mesyuarat ACCSQ-TMHS PWG adalah untuk mewujudkan harmonisasi dalam skim keperluan teknikal dan garis panduan regulatori untuk produk TMHS bagi mengurangkan halangan teknikal perdagangan di rantau ASEAN di samping menyumbang kepada inisiatif Integrasi Ekonomi ASEAN tanpa menjejaskan kualiti, keselamatan dan efikasi produk.

Apart from hosting the 27th ACCSQ-PPWG meeting in June 2019, NPRA also hosted the 32nd ASEAN Consultative Committee for Standards and Quality - Traditional Medicines and Health Supplements Product Working Group (ACCSQ-TMHS PWG) meeting, which was held at Royale Chulan Damansara Hotel, Selangor from 4th to 8th November 2019.

Government officials from the National Drug Regulatory Agencies as well as members of the TMHS industry from all the ASEAN member states attended the 5-day programme. The total amount of participants was 118. The meeting was formally officiated on 7th November 2019 by Dr Ramli Zainal, Senior Director of Pharmaceutical Services Programme, Ministry of Health.

The main objective of the ACCSQ-TMHS PWG meeting is to harmonize the technical requirements and guidelines for TMHS products in order to reduce technical barriers to trade in the ASEAN region and contribute to the ASEAN Economic Integration initiatives without compromising the safety, quality and efficacy/claimed benefits of the products.

MESYUARAT ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS PRODUCT WORKING GROUP (ACCSQ- TMHS) YANG KE-32THE 32ND ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS PRODUCT WORKING GROUP (32ND ACCSQ-TMHS PWG 2019)

33

Imej 7 : Sesi Perasmian Mesyuarat ACCSQ-TMHS PWG ke-32 oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal

Imej 8 : Ketua Perwakilan daripada negara anggota ASEAN

Image 7 : The 32nd ACCSQ-TMHS PWG Meeting was officiated by the Senior Director of Pharmaceutical Services Programme, Dr. Ramli Zainal

Image 8 : The Heads of Delegates from the ASEAN member states


Imej 9 : Participants of the ASEAN TMHS GMP Taskforce Meeting

Imej 10 : Majlis makan malam sempena Mesyuarat ACCSQ-TMHS PWG ke-32

Image 9 : Peserta Mesyuarat ASEAN TMHS GMP Taskforce

Image 10 : Dinner reception in conjunction to the 32nd ACCSQ-THMS PWG Meeting

35

PROGRAM LATIHAN VACCINE LOT RELEASE UNTUK AGENSI REGULATORI NEGARA-NEGARA OICVACCINE LOT RELEASE TRAINING PROGRAMME FOR REGULATORY AUTHORITIES IN THE ORGANISATION OF ISLAMIC COOPERATION (OIC) MEMBER STATES

NPRA telah menganjurkan Program Latihan Vaccine Lot Release khas untuk Badan Regulatori dari negara-negara anggota Kerjasama Islam (OIC) dari 21hb hingga 23hb Oktober 2019 bertempat di Hotel Best Western Petaling Jaya. Program latihan ini dibiayai sepenuhnya oleh Bank Pembangunan Islam (IsDB). Pihak penganjur telah mendapat sambutan yang menggalakkan daripada semua negara anggota, tetapi penganjur hanya dapat menerima 21 peserta untuk latihan ini berdasarkan peruntukan kewangan yang sedia ada.

21 peserta dari 20 negara telah menghadiri program latihan ini. Negara-negara tersebut adalah – Azerbaijan, Comoros, Mesir, Guinea, Jordan, Bahrain, Mali, Maghribi, Mozambique, Niger, Nigeria, Oman, Senegal, Sierra Leon, Somalia, Gambia, Togo, Turki, Uzbekistan dan Yemen.

Program latihan ini merupakan salah satu inisiatif Malaysia dari segi pembangunan kapasiti di dalam Thematic Area 4 - Vaccines, Pharmaceuticals & Medical Technologies under the OIC Strategic Health Programme of Action (SHPA).

Ini adalah program latihan ke-4 yang telah dianjurkan oleh NPRA sejak tahun 2013 di bawah inisiatif OIC SHPA. Tujuan program ini adalah untuk membantu negara anggota memperkukuhkan kawalan regulatori mereka terhadap ubat-ubatan di negara-negara OIC.

Sebelum ini, Malaysia telah menganjurkan 3 sesi latihan bertajuk Pharmaceutical Regulatory System Training Programme. Sesi pertama diadakan pada 25 & 26 November 2013 dan melibatkan 13 peserta dari 9 negara. Sesi kedua diadakan pada 14-18 Mac 2016 dan melibatkan 8 peserta dari 8 negara. Sesi ketiga diadakan pada 25-29 September 2017 dan melibatkan 12 peserta dari 10 negara.

Program ini bertujuan untuk memperkenalkan sistem regulatori yang digunapakai di Malaysia yang selaras dengan keperluan antarabangsa. Objektif program termasuk memaklumkan komitmen Malaysia dalam memastikan produk perubatan di pasaran selamat untuk digunakan, berkesan & berkualiti.

NPRA organised The Vaccine Lot Release Training Programme for Regulatory Authorities in the Organisation of Islamic Cooperation (OIC) Member States from 21st - 23rd Oct 2019 at Best Western Petaling Jaya Hotel. The training programme is fully funded by the Islamic Development Bank (IsDB). The organisers have received overwhelming responses from all the member states, but due to the available budget allocation, the organisers are only able to receive 21 participants for this training.

21 participants from 20 countries attended this training programme. The countries are – Azerbaijan, Comoros, Egypt, Guinea, Jordan, Kingdom of Bahrain, Mali, Morocco, Mozambique, Niger, Nigeria, Oman, Senegal, Sierra Leon, Somalia, The Gambia, Togo, Turkey, Uzbekistan and Yemen.

This training programme is one of Malaysia’s capacity building initiatives in the Thematic Area 4 - Vaccines, Pharmaceuticals & Medical Technologies under the OIC Strategic Health Programme of Action (SHPA).

This is the 4th training programme organised by NPRA since 2013 under the OIC SHPA initiatives. The aim of these programmes is to assist the member states to strengthen their regulatory control of medicines in the OIC region.

Previously, Malaysia has organised 3 training sessions entitled the “Pharmaceutical Regulatory System Training Programme”. The first session was held on 25 & 26 November 2013 and it involved 13 participants from 9 countries. The second session was held on 14-18 March 2016 and it involved 8 participants from 8 countries. The third session was held on 25-29 September 2017 and it involved 12 participants from 10 countries.

The programme aims to share Malaysia’s regulatory systems which in line international requirements and Malaysia’s commitment in ensuring the medicinal products in the market are safe for consumption, effective & of good quality.


Imej 11 : Peserta Program Latihan Vaccine Lot Release

Image 11 : Participants of the Vaccine Lot Release Training Programme

The first and second training sessions include presentation on Product Registration Process, Post Registration Activities including surveillance & pharmacovigilance, GMP Inspection, Clinical Trials and laboratory testing. The sessions also provided an opportunity for participants to visit Malaysia’s leading pharmaceutical manufacturer.

The third training programme focused on Vaccine & blood product registration, biosimilars requirements as well as cold chain requirements. The 4th training focused on vaccine lot release activities. The aim is for the participants to understand the concept of Vaccine Lot Release and able to implement this activity as one of the mechanisms of quality control of vaccines in their respective countries. This session provided an opportunity for participants to visit Malaysia’s leading pharmaceutical importer.

Sesi latihan pertama dan kedua merangkumi topik berkaitan proses pendaftaran produk, aktiviti pasca pendaftaran produk termasuk pengawasan & farmakovigilans, pemeriksaan APB, clinical trials dan pengujian makmal. Sesi ini melibatkan lawatan para peserta ke salah satu premis pengilang farmaseutikal di Malaysia.

Program latihan ketiga lebih memberi penekanan kepada pendaftaran vaksin & produk darah, keperluan biosimilar serta keperluan rantai sejuk. Latihan ke-4 ini pula memberi tumpuan kepada aktiviti vaccine lot release. Matlamatnya adalah untuk peserta memahami konsep vaccine lot release dan dapat melaksanakan aktiviti ini sebagai salah satu mekanisme kawalan kualiti vaksin di negara masing-masing. Untuk latihan kali ini, para peserta diberi peluang melawat salah satu pengimport farmaseutikal terkemuka di Malaysia.

37

Imej 14 : Lawatan ke gudang penyimpanan untuk melihat akiviti Lot Release

Imej 13 : Sesi kerja kumpulan

Image 14 : Site visit to the warehouse to observe the lot release activtiy

Image 13 : Group discussion session

Imej 12 : Kata-kata aluan oleh Pengarah NPRA, Datin Dr. Faridah Aryani Md

YusofImage 12 : Welcoming address by the

director of NPRA, Datin Dr. Faridah Aryani Md Yusof


PENYERTAAN KURSUS LUAR NEGARAPARTICIPATION IN OVERSEAS COURSES

Sepanjang tahun 2019, NPRA telah menghantar beberapa orang pegawai untuk menghadiri latihan di luar negara bagi meningkatkan dan memperkukuhkan pengetahuan serta memastikan pegawai NPRA sedia maklum dengan berkaitan amalan regulatori terkini yang digunapakai di peringkat antarabangsa.

Bil.No.

Tajuk LatihanTraining Topic

TarikhDate

PenganjurOrganiser

LokasiVenue

Nama pegawaiOfficer’s name

1.

Workshop to Develop the Knowledge

on the Principle of Traditional Chinese

Medicine and Quality Control of Traditional &

Complementary Medicine Products

22 – 23 April 2019

Department of Thai Traditional & Alternative

Medicine (DTAM), Ministry of Public Health, Thailand

Ministry of Public Health,

Thailand

Mohamed Shahrizan Shahrir

2.

APEC LSIF RHSC CoE in Regulatory Sciences

Pilot Workshop on Pharmacovigilance

23 – 25 April 2019

Peking University Haidian, China1. Ng Wan Ning2. Bavahrni

Subramaniam

3. Global Bio Conference 201926-28 June

2019

Ministry of Food and Drug Safety (MFDS) Republic

of Korea

Grand InterContinental

Seoul Parnas, Korea

1. Aida Haryati Abdul Rahim

2. Chua Hui Ming

4.APEC Pilot CoE in Advance

Therapies

30 July – 2 August

2019APEC Korea

1. Cheong Ooi Jin2. Amirul Mohd

Mahfuz

5.19th International

Vaccinology Course

2 – 6 September

2019

International Vaccine Institute

International Vaccine

Institute (IVI), Seoul National

University

Liew Carmen

6.

APEC Good Registration Management Regulatory

Science Centre of Excellence Workshop

17-19 September

2019APEC Taipei, Taiwan

1. Elizabeth Chong May Foong

2. Khirul Falisa

Throughout 2019, NPRA sent several officers to attend training overseas to enhance and strengthen their knowledge and to ensure the officers are equipped with the latest information on internationally adopted regulatory practices.

39

Bil.No.

Tajuk LatihanTraining Topic

TarikhDate

PenganjurOrganiser

LokasiVenue

Nama pegawaiOfficer’s name

7.Global Learning

Opportunity: Vaccine Lot Release Training

15 – 24 October

2019

NIFDS, South Korea/WHO

NIFDS, Osong Campus, South

Korea

1. Tan Kuan Chuan2. Nee Yuan Qi

8.

WHO Implementation Workshop on Regulatory

Preparedness for provision and marketing authorisation of human

pandemic influenza vaccines is non-producing

countries

5-8 November

2019WHO

Manila, Phillipines

1. Jenny Thong Chen Ni

2. Sunitha Esther

9.

APEC LSIF RHSC CoE in Regulatory Science

Workshop (MRCT and GCP-related Considerations

11-14 November

2019Peking University Haidian, China

1. Dr Zaril Harza2. Nicholas Leow

10.APEC Centre of Excellence in Biotherapeutics Training

3-5 December

2019APEC

Boston, United States of America

1. Tan Yun Min2. Cher Chae

Miang

11.PMDA-ATC Quality Control (Herbal Medicines) Seminar

2019

10-12 December

2019

Pharmaceutical and Medical

Devices Agency (PMDA), Japan

Toyama Prefectural Hall,

Toyama City, Japan

Nik Juzaimah Juhari


Selain daripada menyertai seminar luar negara, NPRA berbesar hati menerima jemputan menjadi penceramah bagi seminar anjuran agensi regulatori luar negara. Senarai penceramah adalah seperti di bawah:-

In addition to participating in overseas seminars, NPRA officers were also invited to be speakers for seminars organized by overseas regulatory agencies. The list of speakers is as below:-

Bil.No.

Tajuk CeramahPresentation Topic

TarikhDate

PenganjurOrganizer

LokasiVenue

PenceramahSpeaker

1.CoRE’s Chemistry, Manufacturing and

Controls (CMC)20 Mac 2019

Centre of Regulatory

Excellenc (CoRE)-DUKE-NUS

Singapore Lim Bee Yee

2.Access To Innovative Medicine (ATIM): post

approval changes9 April 2019

Japan Pharmaceutical Manufacturing

Association (JPMA)

Tokyo, JapanSiti Hidayah binti

Kasbon

3.

National Regulatory Agency of Malaysia and our Role in Improving

Patient’s Access to Biologics Products

28 June 2019 WHOSeoul, South

KoreaChua Hui Ming

4.Requirement of the Registration of New

Products

8 September 2019

China-Asean Summit For Drug

Development And Cooperation

Guangxi, ChinaMajidah binti Abd

Rahman

5.Regulatory innovation at

NPRA, Malaysia12 October

2019

Asian Society of Neuropsycho-pharmacology

Fukuoka, JapanDr. Yvonne Khoo

Siew Khoon

6.

Regulatory Preparedness on

Authorisation for use of Influenza vaccines

5 November 2019

WHOManila,

PhilippinesJenny Thong Chen

Ni

7.

The Appropriate Use of Drugs in Asia Countries,

Especially in Elderly Patients

11 November 2019

Drug Information Association

Tokyo, Japan Azri Bin Nasruddin

41

LAWATAN DARIPADA AGENSI DALAM DAN LUAR NEGARA SERTA PELAJAR UNIVERSITIVISITS BY LOCAL AND INTERNATIONAL AGENCIES AS WELL AS UNIVERSITY STUDENTS

NPRA telah mendapat pengiktirafan antarabangsa sebagai WHO Collaborating Centre for Regulatory Control of Pharmaceuticals pada tahun 1996. Pengiktirafan ini telah diberikan oleh Pertubuhan Kesihatan Dunia (WHO) atas sumbangan NPRA dalam bidang regulatori farmasi. Sepanjang 2019, NPRA telah menerima kunjungan daripada 41 orang pelawat antarabangsa daripada 9 negara - Bangladesh, Brunei, China, Kenya, Taiwan, Tanzania, Thailand, Uganda dan Vietnam.

Skop latihan termasuk Pemeriksaan Amalan Pengilangan Baik (GMP), validasi kaedah pengujian dan peralatan makmal, penguijan kimia & mikrobiologi ke atas produk farmaseutikal, suplemen kesihatan, produk tradisional dan produk kosmetik serta aktiviti pasca pendaftaran termasuk surveilans dan farmakovigilans ubat-ubatan.

The NPRA has been given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization (WHO) for NPRA’s contribution in the field of regulatory affairs. This recognition has attracted foreign regulatory agencies to undergo training in NPRA. Throughout 2019, NPRA has received visits from 41 international visitors from 9 countries - Bangladesh, Brunei, China, Kenya, Taiwan, Tanzania, Thailand, Uganda dan Vietnam.

The scope of training includes Good Manufacturing Practice inspection, equipment qualification & validation, Chemical & microbiological testing on Pharmaceutical, Health Supplements, Traditional Products & Cosmetics as well as the post-registration activities such as surveillance & pharmacovigilance of medicines.

Imej 15 : Latihan sangkutan oleh pegawai daripada National Drug Authority Uganda utuk mempelajari

Kawalan regulatori ubat-ubatan tradisionalImage 15 : Training attachment by officers from the

National Drug Authority Uganda to learn on regulatory control of traditional medicines

(15-19 April 2019)


Imej 16 : Lawatan kerja oleh pegawai daripada Food and Drug Administration of Guangxi Zhuang Autonomous Region China

Imej 17 : Latihan sangkutan oleh pegawai daripada Drug Administration of Vietnam untuk mempelajari penggunaan aplikasi IT di dalam proses

pendaftaran produk

Image 16 : Work Visit from officers of the Food and Drug Administration of Guangxi Zhuang Autonomous Region China.

(24 June 2019)

Image 17 : Training attachment by officers from the Drug Administration of Vietnam to learn on training for evaluators and IT

application in drug registration (1-2 July 2019)

43

Sepanjang tahun 2019, NPRA telah menerima lawatan kerja daripada seorang orang pegawai daripada Makmal Kesihatan dan Keselamatan Makanan dan dua orang pegawai farmasi daripada Pusat Panggilan Farmasi Kebangsaan (NPCC). Lawatan ini bertujuan untuk memahami proses kerja di NPRA bagi membantu pegawai-pegawai ini dalam tugasan harian mereka.

Selain itu, NPRA juga telah menerima lawatan sambil belajar daripada 82 orang pelajar daripada universiti dan kolej tempatan iaitu pelajar sarjana muda Biologi Farmaseutikal dan pelajar ijazah sarjana Kesihatan Awam daripada Universiti Malaya serta pelajar sarjana muda jurusan farmasi daripada Kolej MAHSA.

Throughout the year 2019, NPRA received work visits from one officer from the Food and Health Safety Laboratory and two pharmacists from the National Pharmacy Call Center. This visit aims to gain a deeper understanding of the work processes in NPRA to assist these officers in their daily tasks.

In addition, NPRA also received study visits from 82 students from local universities and colleges which are the Pharmaceutical Biology undergraduate students and Public Health postgraduate students from the University of Malaya as well as undergraduate students in the pharmacy program from MAHSA College.

Imej 18 : Lawatan akademik oleh pelajar sarjana muda Biologi Farmaseutikal, Universiti Malaya

Image 18 : Academic Visit by the Pharmaceutical Biology undergraduate students from University Malaya

(8 April 2019)


Imej 19 : Lawatan kerja oleh pegawai daripada Makmal Kesihatan dan Keselamatan Makanan

Imej 20 : Lawatan akademik oleh pelajar ijazah sarjana Kesihatan Awam daripada Universiti Malaya

Image 19 : Work visit by officers from the Food and Health Safety Laboratory.

(31 July 2019)

Image 20 : Academic visit from Public Health postgraduate students from the University of Malaya

(12 December 2019)

45

BENGKEL PELAPORAN KESAN ADVERS UBAT (ADR) DAN CAUSALITY ASSESSMENT ADVERSE DRUG REACTION AND CAUSALITY ASSESSMENT WORKSHOPS

Sepanjang tahun 2019, NPRA telah mengadakan empat (4) bengkel berkenaan pelaporan kesan advers ubat (adverse drug reaction – ADR) dan kesan advers berikutan pelalian (adverse events following immunisation – AEFI) serta causality assessment. Kesemua bengkel ini telah diadakan secara berperingkat bagi memastikan penglibatan dari ahli farmasi yang mewakili fasiliti kesihatan di seluruh Malaysia

1. Bengkel Penganalisaan dan Causality Assessment Laporan Kesan Advers Ubat dan Vaksin

Bengkel Penganalisaan dan Causality Assessment Laporan Kesan Advers Ubat dan Vaksin telah diadakan pada 25 Februari 2019 di NPRA. Bengkel ini disertai oleh 49 pegawai farmasi daripada fasiliti kesihatan Kementerian Kesihatan Malaysia (KKM) di sekitar Lembah Klang. Objektif bengkel ini adalah untuk memperkukuhkan kemahiran menganalisa serta membuat causality assessment terhadap laporan ADR/AEFI serta mempertingkatkan kualiti pelaporan ADR/AEFI. Selain itu, peserta mendapat pendedahan kepada kaedah penilaian sistem regulatori World Health Organisation Global Benchmarking Tool yang digunapakai di Malaysia dan serata dunia.

Throughout 2019, NPRA organised four (4) workshops related to adverse drug reactions (ADR) and adverse events following immunisation (AEFI) reporting, as well as causality assessment. These workshops were conducted in stages to cover a range of pharmacists from various health institutions in the country.

1. ADR/AEFI Report Analysis and Causality Assessment Workshop

The ADR/AEFI Report Analysis and Causality Assessment Workshop was held on 25 February 2019 at NPRA. The participants consisted of 49 pharmacists from the Ministry of Health (MOH) facilities in the Klang Valley. The objective of this workshop was to sharpen the skills in analysing ADR/AEFI reports and assessing the causality of these reports, as well as to improve the quality of ADR/AEFI reports. Participants also gained exposure on the World Health Organisation (WHO) Global Benchmarking Tool – a regulatory system assessment method that is used in Malaysia and worldwide.


Imej 21 : Bengkel Penganalisaan dan Causality Assessment Laporan Kesan Advers Ubat dan Vaksin

Imej 22 : Program Peningkatan Kesedaran Pelaporan Kesan Advers Ubat dan Vaksin

Image 21 : ADR/AEFI Report Analysis and Causality Assessment Workshop.(25 February 2019)

Image 22 : ADR/AEFI Reporting Awareness Programme(19 March 2019)

47

2. Program Peningkatan Kesedaran Pelaporan Kesan Advers Ubat dan Vaksin

Program ini telah diadakan di NPRA pada 19 Mac 2019 dan melibatkan 26 orang peserta, iaitu ahli farmasi dari hospital swasta serta pegawai farmasi daripada fasiliti kesihatan Kementerian Pertahanan Malaysia dan Kementerian Pendidikan Tinggi Malaysia. Program ini bertujuan untuk meningkatkan kesedaran berkaitan pelaporan ADR/AEFI dan mempertingkatkan kualiti pelaporan ADR/AEFI bagi menjana isyarat keselamatan ubat (drug safety signal) yang lebih tepat. Selain itu, pengenalan kepada klasifikasi causality assessment baru bagi pelaporan AEFI juga telah dibentangkan.

3. Bengkel Pemurnian Garis Panduan Farmakovigilans Vaksin untuk Anggota Kesihatan

Bengkel ini telah diadakan pada 18-19 September 2019 di NPRA. Tumpuan utama bengkel ini adalah untuk mengemaskini secara menyeluruh kandungan Garis Panduan Farmakovigilans Vaksin untuk Anggota Kesihatan, susulan perbincangan semasa mesyuarat Jawatankuasa Farmakovigilans Vaksin yang telah berlangsung pada 17 Julai 2019.

Sejumlah 10 orang peserta yang terdiri daripada pakar perubatan, pegawai perubatan, dan pegawai farmasi telah menghadiri bengkel ini. Mereka mewakili hospital universiti, Persatuan Perubatan Malaysia, Persatuan Pediatrik Malaysia, beberapa sektor di Kementerian Kesihatan Malaysia seperti Bahagian Kawalan Penyakit, Bahagian Pembangunan Kesihatan Keluarga, dan Bahagian Amalan dan Perkembangan Farmasi dan Kementerian Pembangunan Wanita, Keluarga dan Masyarakat.

2. ADR/AEFI Reporting Awareness Programme

This pogramme was held at NPRA on 19 March 2019 and involved 26 participants; pharmacists from private hospitals as well as pharmacists from the Ministry of Defence and university hospitals under the Ministry of Higher Education. This programme aimed to increase the awareness on ADR/AEFI reporting and improve the quality of ADR/AEFI reports, which subsequently would help in generating more accurate drug safety signals. In addition, the new classification of AEFI causality assessment was also presented during this programme.

3. Workshop on Vaccine Pharmacovigilance Guidelines for Healthcare Members

This two-day workshop was conducted on 18-19 September 2019 in NPRA. The main focus of this workshop was to structurally organise and update the contents of the Malaysian Vaccine Pharmacovigilance Guidelines for Healthcare Professionals, following discussions during the Vaccine Pharmacovigilance Organising Committee meeting held on 17 July 2019.

Ten (10) participants comprised of specialists, doctors and pharmacists attended this workshop. They were representatives from University Malaya Medical Centre, Malaysian Medical Association, Malaysian Paediatric Association, various public health divisions in the Ministry of Health including the Disease Control Division, Development of Family Health Division, and Pharmacy Practice & Development Division and the Ministry of Women, Family and Community Development.


4. Advanced Workshop for Training of Trainers on Adverse Drug Reactions and Vaccines Reporting

The Advanced Workshop for Training of Trainers on Adverse Drug Reactions and Vaccines Reporting was a three-day course held on 14-16 October 2019 at Hotel Premiere in Bukit Tinggi 1, Klang. A total of 38 pharmacists representing different states in Malaysia whom were in charge of ADR/AEFI report preparation, evaluation and management in the health facilities were invited to attend the training. This is to enhance their capabilities in serving as contact points for matters regarding ADR/AEFI reporting within their states.

Among the objectives of this workshop were to strengthen the understanding on ADR/AEFI reporting, to train pharmacists regarding information completeness in ADR/AEFI reporting in order to generate accurate drug safety signals, as well as to provide exposure on WHO standards for causality assessment. This workshop also provided a platform for participants to discuss issues related to adverse drug events and vaccines, as well as ways on how to manage them.

4. Bengkel Lanjutan Training of Trainers bagi Pelaporan Kesan Advers Ubat dan Vaksin

Bengkel Lanjutan Training of Trainers bagi Pelaporan Kesan Advers Ubat dan Vaksin telah dianjurkan pada 14 – 16 Oktober 2019 di Hotel Premiere, Bandar Bukit Tinggi 1, Klang. Seramai 38 pegawai farmasi KKM mewakili setiap negeri di Malaysia yang bertanggungjawab untuk menyelaras, mengendalikan dan menyediakan laporan ADR/AEFI di fasiliti masing-masing telah dijemput untuk menjalani latihan ini. Ini bagi meningkatkan kemahiran mereka sebagai pegawai rujukan bagi perkara berkaitan ADR dan AEFI di negeri masing-masing.

Di antara sasaran bengkel ini adalah bagi memperkukuhkan kefahaman terhadap pelaporan ADR/AEFI, melatih pegawai farmasi tentang keperluan maklumat yang lengkap dalam pelaporan ADR/AEFI untuk menjana isyarat keselamatan ubat (drug safety signal) yang lebih tepat, dan juga memberikan pendedahan tentang penilaian causality bagi menentukan hubungkait di antara kesan advers ubat atau vaksin berdasarkan standard WHO. Selain itu, bengkel ini membuka peluang kepada peserta untuk membincangkan isu-isu terkini berkaitan kesan advers ubat dan vaksin serta cara menanganinya.

Imej 23 : Bengkel Lanjutan Training of Trainers bagi Pelaporan Kesan Advers Ubat dan Vaksin

Image 23 : Advanced Workshop for Training of Trainers on Adverse Drug Reactions and Vaccines Reporting. (14-16 October 2019)

49

PENGLIBATAN & KOLABORASI ANTARABANGSA

INTERNATIONAL PARTICIPATION &

COLLABORATIONS


PENGLIBATAN NPRA DI DALAM KUMPULAN KERJA ASEANNPRA’S PARTICIPATION IN ASEAN WORKING GROUPS

ASEAN Consultative Committee for Standards and Quality (ACCSQ) telah ditubuhkan pada tahun 1992 bagi memudahkan pencapaian objektif Perjanjian Perdagangan Bebas ASEAN. Pada tahun 2004, ACCSQ telah ditugaskan untuk menjalankan aktiviti-aktiviti yang berkaitan dengan penubuhan ASEAN Economic Community (AEC).

AEC dilancarkan pada 2015 dengan tujuan untuk mewujudkan pasaran tunggal di kalangan negara-negara ASEAN. Ini akan membolehkan pergerakan bebas barangan, perkhidmatan, buruh mahir dan pelaburan di kalangan 10 negara anggota ASEAN serta memudahkan aliran bebas modal. Pengharmonian peraturan-peraturan teknikal dan Mutual Recognition Agreements (MRA) adalah antara strategi yang akan digunapakai oleh AEC untuk mengurangkan kos perdagangan.

Malaysia, melalui NPRA giat mengambil bahagian dalam aktiviti tiga kumpulan kerja yang ditubuhkan untuk pembangunkan skim pengharmonian produk farmaseutikal, ubat-ubatan tradisional dan suplemen kesihatan serta peraturan kosmetik di negara-negara ASEAN. Terdapat tiga kumpulan kerja di bawah ACCSQ, iaitu Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) dan the ASEAN Cosmetic Committee (ACC).

Pada tahun 2019, NPRA diberi peluang untuk menganjurkan dua mesyuarat kumpulan kerja ACCSQ iaitu Mesyuarat ACCSQ-PPWG yang ke-27 di Pulau Pinang dan Mesyuarat ACCSQ-TMHS PWG yang ke-32 di Selangor.

The ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed in 1992 to facilitate the accomplishment of the objectives of the ASEAN Free Trade Agreement. In 2004, the ACCSQ was tasked to undertake activities in relation to the establishment of an ASEAN Economic Community (AEC).

Launched in 2015, the AEC aims to eventually create a single market and production base within ASEAN countries. This will allow for the free movement of goods, services, skilled labour and investment among the 10 ASEAN member nations and facilitate the free flow of capital. Harmonisation of technical regulations and mutual recognition agreements (MRA) are among the strategies that will be adopted by the AEC to reduce trade cost.

Through the NPRA, Malaysia actively participates in three product-working groups which aim to develop harmonisation schemes of pharmaceuticals, traditional medicines and health supplements as well as cosmetics regulations in ASEAN countries. There are three working groups under the ACCSQ – the Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) and the ASEAN Cosmetic Committee (ACC).

In the year 2019, NPRA had the opportunity to organise two meetings for the ACCSQ working group which are the 27th ACCSQ-PPWG Meeting in Penang and the 32nd ACCSQ-TMHS PWG Meeting in Selangor.

51

Berikut merupakan mesyuarat peringkat ASEAN yang telah dihadiri oleh pegawai NPRA sepanjang tahun 2019:

Below are the ASEAN meetings attended by NPRA officers in the year 2019:

No. Meeting Date Venue

1.

The 30th Meeting of the ASEAN Consultative Committee for Standards and Quality on Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG Meeting)

29 April – 3 May 2019 Lao PDR

2. The 13th ASEAN Cosmetic Testing Laboratory Meeting 18-19 June 2019 Myanmar

3. The 30th ASEAN Cosmetic Committee (ACC) 18-21 June 2019 Myanmar

4. The 31st ASEAN Cosmetic Committee (ACC) 12-15 November 2019 Philippines

5.Joint Sectoral Committee for ASEAN Mutual Recognition Agreement for GMP Inspection of Manufacturers of Medicinal Products Meeting

15-21 December 2019 Indonesia

6.28th ACCSQ Pharmaceutical Product Working Group & its Related Meetings

15-21 December 2019 Indonesia

7. 4th Joint Assessment Coordinating Group (JACG) Meeting 16-20 December 2019 Indonesia


MESYUARAT DUA HALA DI ANTARA BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) DAN PHARMACEUTICAL AND MEDICAL DEVICE AGENCY (PMDA), JEPUNBILATERAL MEETING BETWEEN THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA) AND PHARMACEUTICAL AND MEDICAL DEVICE AGENCY (PMDA), JAPAN

Mesyuarat Teknikal di antara Bahagian Regulatori Farmasi Negara (NPRA) dan The Pharmaceutical and Medical Device Agency (PMDA), Jepun telah diadakan pada 12 September 2019 bertempat di Bilik Mesyuarat Delima, Pejabat Program Perkhidmatan Farmasi. Delegasi Malaysia telah diketuai oleh YBhg. Dr. Ramli Zainal, Pengarah Kanan Perkhidmatan Farmasi, manakala delegasi PMDA diketuai oleh Dr. Nobumasa Nakashima, Pengarah, Pengarah Kanan Program Antarabangsa, PMDA.

Mesyuarat ini merupakan susulan kepada mesyuarat di antara kedua-dua agensi yang telah diadakan pada 8 April 2019 di PMDA, Jepun yang telah dihadiri oleh YBhg. Dr. Ramli Zainal dan seorang pegawai NPRA, Pn. Noraisyah Mohd Sani. Mesyuarat kali ini telah membincangkan projek rintis untuk facilitated registration bagi beberapa produk di mana PMDA akan berkongsi laporan penilaian mereka dengan NPRA bagi mempercepatkan proses pendaftaran produk tersebut di Malaysia. Selain itu, mesyuarat turut membincangkan perancangan aktiviti latihan pada masa akan datang.

The Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA) and The Pharmaceutical and Medical Device Agency (PMDA), Japan was held on 12 September 2019 at the Delima Meeting Room, Pharmaceutical Services Programme. The Malaysian delegation was headed by YBhg. Dr. Ramli Zainal, Senior Director of Pharmaceutical Services, Ministry of Health Malaysia, whereas the Japanese delegation was led by Dr. Nobumasa Nakashima, Senior Director for International Programs, PMDA.

The meeting was a follow-up from another meeting between the two agencies held on 8th April 2019 in PMDA, Japan which was attended by YBhg. Dr. Ramli Zainal and an NPRA officer, Pn. Noraisyah Mohd Sani. This bilateral meeting discussed on the pilot study for facilitated registration for some products whereby PMDA will share their evaluation report with NPRA to expedite the process of registering the product in Malaysia. In addition, the meeting also discussed plans for future training activities.

53

Imej 24 : Mesyuarat Dua Hala di antara Bahagian Regulatori Farmasi Negara dan Pharmaceutical and Medical Device Agency pada 12

September 2019 di Petaling Jaya, Selangor

Imej 25 : Mesyuarat Dua Hala di antara Bahagian Regulatori Farmasi Negara dan Pharmaceutical and Medical Device Agency pada 12

September 2019 di Petaling Jaya, Selangor

Image 24 : Bilateral Meeting between National Pharmaceutical Regulatory Agency and Pharmaceutical and Medical Device Agency

on 12 September at Petaling Jaya, Selangor

Image 25 : Bilateral Meeting between National Pharmaceutical Regulatory Agency and Pharmaceutical and Medical Device Agency

on 12 September at Petaling Jaya, Selangor


MESYUARAT TEKNIKAL DUA HALA KE-7 DI ANTARA BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) DAN HEALTH SCIENCES AUTHORITY (HSA), SINGAPURA7TH TECHNICAL BILATERAL MEETING BETWEEN THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA), MINISTRY OF HEALTH MALAYSIA

Mesyuarat Teknikal Ke-7 di antara Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM) dan Health Sciences Authority (HSA), Singapura telah diadakan pada 12 November 2019 bertempat di premis Bilik Persidangan, Hospital Permai, Johor Bahru. Delegasi Malaysia telah diketuai oleh YBhg. Dr. Ramli Zainal, Pengarah Kanan Perkhidmatan Farmasi, KKM manakala delegasi Singapura telah diketuai oleh Associate Professor. Chan Cheng Leng, Pengarah, Bahagian Regulatori Produk Kesihatan, HSA Singapura.

Mesyuarat telah membincangkan maklumat regulatori terbaru daripada kedua-dua agensi termasuk perkongsian aktiviti mengesan dan mengendalikan situasi yang memerlukan tindakbalas segera serta kerjasama berterusan dalam pelbagai bidang termasuk aktiviti workshare model dan perancangan aktiviti latihan pada masa akan datang.

The 7th Technical Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia and Health Sciences Authority (HSA), Singapore was held on 12 November 2019 at the Conference Room, Permai Hospital, Johor Bahru. The Malaysian delegation was headed by YBhg. Dr. Ramli Zainal, Senior Director of Pharmaceutical Services, Ministry of Health Malaysia, whereas the Singapore delegation was led by Associate Professor. Chan Cheng Leng, Group Director of the Health Product Regulation Group.

The meeting discussed regulatory updates from both agencies including a sharing session on the detection and handling of situations that require immediate response as well as the continuous collaboration between the two agencies in various fields including the on-going workshare model activity and future training activities.

55

Imej 26 : Mesyuarat Teknikal Dua Hala Ke-7 di antara Bahagian Regulatori Farmasi Negara dan Health Sciences Authority pada 12

November 2019 di Johor Bahru

Imej 27 : Sesi pemberian hadiah semasa penutup Mesyuarat Teknikal Dua Hala Ke-7 di antara Bahagian Regulatori Farmasi Negara dan Health Sciences Authority pada 12 November 2019 di Johor Bahru

Image 26 : The 7th Technical Bilateral Meeting between National Pharmaceutical Regulatory Agency and the Health Sciences Authority

on 12 November 2019 at Johor Bahru

Image 27 : Gift exchange during the closing of the 7th Technical Bilateral Meeting between National Pharmaceutical Regulatory Agency and the

Health Sciences Authority on 12 November 2019 at Johor Bahru


PENGLIBATAN NPRA DI DALAM AKTIVITI-AKTIVITI DI PERINGKAT OICNPRA’S INVOLVEMENT IN ACTIVITIES AT THE OIC LEVEL

Sesi ke-4 Persidangan Islam Menteri-menteri Kesihatan (ICHM), yang telah diadakan di Jakarta pada 22 – 24 Oktober 2013, telah menerimapakai OIC Strategic Health Programme of Action 2014 - 2023 (OIC-SHPA), yang telah disediakan dan dikemukakan oleh SESRIC dengan kerjasama negara-negara ahli OIC dan pertubuhan antarabangsa yang berkaitan.

OIC-SHPA telah disediakan dengan tujuan mengukuhkan dan meningkatkan kerjasama dalam pelbagai isu kesihatan di peringkat OIC dan peringkat antarabangsa. OIC-SHPA telah mengenalpasti enam bidang tematik untuk tindakan bersama dan Malaysia telah dilantik untuk manjadi penyelaras utama bagi Thematic Area 4: Medicine, Vaccine and Medical Technologies. Sebagai penyelaras utama, Malaysia bertanggungjawab memastikan aktiviti yang dirancang di bawah Thematic Area ini dilaksanakan mengikut perancangan. Malaysia juga mengambil bahagian dan memberikan input bagi Thematic Area lain apabila diperlukan.

Malaysia melalui NPRA aktif menjalankan aktiviti seperti sesi latihan untuk membantu negara-negara anggota OIC meningkatkan kawalan regulatori terhadap ubat-ubatan dan vaksin di negara masing-masing. NPRA berpegang teguh kepada prinsip di mana negara yang mempunyai sistem kawalan regulatori yang kukuh dapat meningkatkan akses kepada ubat-ubatan dan vaksin yang berkualiti, berkesan dan selamat.

Malaysia juga mengambil bahagian secara aktif dalam mesyuarat-mesyuarat OIC seperti Lead Country Coordinators (LCC) Meeting and the Steering Committee of Health Meeting (SCH) yang dijalankan setiap tahun serta International Conference of the Health Ministers Meeting (ICHM) yang diadakan sekali setiap dua tahun.

Pada tahun 2019, wakil NPRA, Pn. Syuhadah Mohamed Hassan telah menghadiri Mesyuarat LCC ke-6 dan Mesyuarat SCH ke-13 yang telah diadakan di Abu Dhabi, United Arab Emirates pada 7-8 Oktober 2019.

The 4th Session of the Islamic Conference of Ministers of Health (ICHM), which was held in Jakarta on 22 – 24 October 2013, adopted the OIC Strategic Health Programme of Action 2014 - 2023 (OIC-SHPA), which was prepared and submitted by SESRIC in collaboration with OIC member countries and relevant international organisations.

The OIC-SHPA was prepared with a view to strengthen and enhance cooperation and collaboration on various health issues at both OIC and international level. The OIC-SHPA identified six thematic areas for joint action and Malaysia was elected as the lead country coordinator for Thematic Area 4: Medicine, Vaccine and Medical Technologies. As the lead country, Malaysia ensures the activities planned under this Thematic Area are carried out in a timely manner. Malaysia also participates and gives input for other Thematic Areas when required.

Malaysia through NPRA actively carries out activities such as in-depth training sessions to assist OIC member states to improve the regulatory control of medicines and vaccines in their country. NPRA believes that having a strong regulatory control system in place will promote better access to good quality, effective and safe medicines and vaccines.

Malaysia also actively participates in the OIC meetings such as the Lead Country Coordinators Meeting (LCC) and the Steering Committee of Health Meeting (SCH) which is carried out annually, as well as the International Conference of the Health Ministers Meeting (ICHM) which is held once in every two years.

In 2019, NPRA’s representative, Mdm. Syuhadah Mohamed Hassan attended the 6th LCC meeting as well as the 13th SCH Meeting held in Abu Dhabi, United Arab Emirates from the 7-8 October 2019.

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During this meeting, Malaysia officially resigned from being the LCC for Thematic Area 4 after leading it for 6 years, which is the maximum length of time for a country to lead a Thematic Area. Our neighboring country, Indonesia, will continue the program planned under Thematic Area 4 beginning in 2020.

At the same time, Malaysia has applied to become the LCC for Thematic Area 3 : Maternal, New-born and Child Health and Nutrition. Future programs under this Thematic Area will be led by the Public Health Development Division, Ministry of Health Malaysia.

Dalam mesyuarat ini, Malaysia telah mengundur diri secara rasmi daripada menjadi LCC bagi Thematic Area 4 setelah menduduki jawatan ini selama 6 tahun, yang merupakan tempoh maksimum sesebuah negara dapat menjadi LCC untuk satu Thematic Area. Negara jiran, Indonesia akan meneruskan program yang telah dirancang di bawah Thematic Area 4 bermula pada tahun 2020.

Pada masa yang sama, Malaysia telah membuat permohonan untuk menjadi LCC yang Thematic Area 3 : Maternal, New-born and Child Health and Nutrition. Program pada masa akan datang di bawah Thematic Area ini akan diketuai oleh Bahagian Perkembangan Kesihatan Awam, Kementerian Kesihatan Malaysia.


Imej 29: Mesyuarat Steering Committee of Health pada 8 October 2019 di Abu Dhabi, UAE

Image 29: Steering Committee of Health Meeting held on 8 October 2019 at Abu Dhabi, UAE

Imej 28 : Mesyuarat Lead Country Coordinators pada 7 October 2019 di Abu Dhabi, UAE

Image 28 : Lead Country Coordinators Meeting held on 7 October 2019 at Abu Dhabi, UAE

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PENGLIBATAN NPRA SELAKU AHLI PASUKAN PENILAI ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) DALAM ON-SITE EVALUATION (OSE) KE ATAS UNITED STATES FOOD & DRUG ADMINISTRATION (USFDA), PADA 5 – 9 OGOS 2019 DI WASHINGTON, D.C.NPRA AS EVALUATION TEAM FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) IN THE ON-SITE (OSE) EVALUATION OF THE UNITED STATES FOOD & DRUG ADMINISTRATION (USFDA), 5 – 9 AUGUST 2019, WASHINGTON, D.C.

OECD Working Group on Good Laboratory Practice (GLP) telah melantik Malaysia dan Republik Czech sebagai negara pasukan penilai OECD bagi OECD On-Site Evaluation (OSE) ke atas Unites States Food & Drug Administration (USFDA). Pasukan penilai OECD bagi OSE USFDA tersebut telah diwakili oleh Cik Fadhilah Hasbullah dari NPRA Malaysia bersama seorang inspektor GLP State Institute for Drug Control (SUKL), Republik Czech. OSE USFDA tersebut telah dijalankan pada 5 hingga 9 Ogos 2019 di Ibu Pejabat USFDA, Washington, D.C. Penyertaan inspektor NPRA mewakili Malaysia dalam OSE tersebut merupakan satu pengiktirafan OECD kepada Program Komplians GLP NPRA dan kompetensi inspektor NPRA.

OECD Working Group on Good Laboratory Practice (GLP) has appointed Malaysia and Czech Republic to be the OECD evaluation team for the On-Site Evaluation (OSE) of the United States Food & Drug Administration (USFDA). OECD evaluation team was represented by Ms. Fadhilah Hasbullah from NPRA Malaysia, and one GLP inspector from State Institute for Drug Control (SUKL), Czech Republic. The USFDA OSE took place in USFDA Head Quarters, Washington, D.C. from 5 to 9 August 2019. NPRA participation in the OSE is a form of recognition by the OECD to the NPRA GLP Compliance Programme and NPRA inspector’s competency.

Imej 30 : Cik Fadhilah Hasbullah (kiri) selaku wakil pasukan penilai OECD

Image 30 : Ms. Fadhilah Hasbullah (left) as a representative of the OECD evaluation team


LAWATAN SEMPENA CAPACITY BUILDING ACTIVITIES BERSAMA TAIWAN FOOD AND DRUG ADMINISTRATION (TFDA), PADA 1 – 5 JULAI 2019, DI TAIPEI, TAIWANCAPACITY BUILDING ACTIVITIES VISIT WITH TAIWAN FOOD AND DRUG ADMINISTRATION (TFDA), 1 – 5 JULY 2019, TAIPEI, TAIWAN

NPRA telah menerima jemputan dari Taiwan Food and Drug Administrations (TFDA) untuk mengambil bahagian dalam Good Laboratory Practice (GLP) Capacity Building Activities, di Taipei pada 1 hingga 6 Julai 2019. Kolaborasi di antara TFDA dan NPRA ini bertujuan untuk meningkatkan capacity building inspektor-inspektor GLP kedua-dua agensi. Lawatan tersebut telah dihadiri oleh tiga inspektor GLP NPRA iaitu Pn. Poh Wen Tsin, Cik Fadhilah Hasbullah dan Pn. Nur Amani Shaari. Antara agenda lawatan adalah menjadi pemerhati semasa pemeriksaan GLP oleh TFDA serta menghadiri Experience Exchange and Technical Discussion Meeting bersama pihak TFDA.

NPRA was invited by Taiwan Food and Drug Administrations (TFDA) to participate in Good Laboratory Practice (GLP) Capacity Building Activities Visit in Taipei, from 1 to 6 July 2019. Collaboration between these two agencies is to enhance the capacity building of GLP inspectors among the two agencies. Three NPRA GLP inspectors, Ms. Poh Wen Tsin, Ms. Fadhilah Hasbullah and, Ms. Nur Amani Shaari attended the capacity building visit. Among activities performed during the visit include observing TFDA on-site GLP inspection, and experience exchange and technical discussion meeting with TFDA.

Imej 31 : Pegawai NPRA bersama pegawai TFDA di Taipei, Taiwan

Image 31 : NPRA officers along with TFDA officers in Taipei, Taiwan

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PENERBITAN

PUBLICATION


Salah satu fungsi utama NPRA adalah untuk memastikan produk farmaseutikal, suplemen kesihatan, dan produk tradisional yang dipasarkan dalam negara adalah selamat dan berkualiti untuk pengguna. NPRA juga turut memainkan peranan penting dalam industri kosmetik negara memandangkan kesemua produk kosmetik yang dipasarkan perlu dinotifikasi dengan pihak NPRA bagi memastikan keselamatan pengguna terjamin.

Justeru, pihak NPRA sedia cakna akan tanggungjawab yang perlu digalas dalam memupuk kesedaran di kalangan pengguna terhadap kepentingan aktiviti kawalan regulatori ke atas produk farmaseutikal, suplemen kesihatan, produk tradisional, dan juga produk kosmetik. Seiring dengan perkembangan dan kemajuan dunia digital seantero dunia, NPRA yakin bahawa penggunaan platform digital dan atas talian akan dapat memudahkan lagi aktiviti penyebaran maklumat dijalankan.

NPRA telah menerbitkan beberapa bahan rujukan dan risalah bagi menyampaikan maklumat-maklumat relevan yang terkini kepada pihak-pihak berkepentingan dan juga para pengguna yang kesemuanya boleh diakses di bawah topik “Maklumat” dan “Newsletters” di laman sesawang rasmi NPRA. Penerbitan – penerbitan ini termasuklah, risalah Berita Ubat-ubatan (BUU) dan buletin MADRAC serta eBrochures yang sangat informatif yang baru diperkenalkan sejak 2019.

eBrochures ini merangkumi topik seperti fungsi utama NPRA, keperluan pendaftaran produk, dan juga beberapa isu semaa seperti vaksin dan produk kosmetik. Maklumat tersebut kini dapat diakses dengan mudah oleh pelbagai lapisan masyarakat dari serata pelusuk negara pada bila-bila masa.

Maklumat dalam eBrochures akan dikemaskini mengikut keperluan dari masa ke semasa, dengan harapan bahan penerbitan ini yang padat dengan informasi dapat memupuk masyarakat untuk lebih cakna terhadap aktiviti regulatori produk farmaseutikal, suplemen kesihatan, produk tradisional, dan kosmetik yang dipasarkan dalam negara.

One of NPRA’s key roles is to ensure that all pharmaceutical products, health supplements, and traditional products available in the country are safe for the consumers and are of good quality. NPRA also plays an important role in the cosmetic industry as all cosmetic products intended for the local market are required to be notified with NPRA for the safety of the consumers.

Consequently, we understand that it is also part of our duty to raise a more profound awareness among the public on the importance and nature of regulatory control on pharmaceutical, health supplements, traditional products, and cosmetics. With the world moving and evolving fast into an enormous digital, online community, it is only wise that we join the crowd, reach out to a broader audience, and benefit from technology.

NPRA has published several reference materials and newsletters to disseminate relevant and updated information to consumers as well as its stakeholders. These materials can be accessed by clicking the “Newsletter” tab under the “Information” tab on NPRA official website. These include the DCA newsletter known as Berita Ubat-ubatan (BUU) and MADRAC Bulletin as well as the newly introduced informative e-brochure which started in 2019.

eBrochures contains a description and overview of our general roles and functions, basic product registration information, and issues related to current hot topics such as vaccines and cosmetic products. People from all walks of life across the country can now have access to this information, just at the click of a button.

Information on the eBrochures will be regularly updated and revised as necessary, in the hope that these concise packs of information, bundled in a variety of eye-catching designs could help engage and interest the public, to get to know more about regulatory control on pharmaceutical, health supplements, traditional products, and cosmetics in Malaysia.

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Throughout 2019, a total of two editions of BUU, two editions of MADRAC Bulletin and six e-brochures were published.

For information on security issues related to the use of medicines, consumers may refer to the “Health Professionals” tab and refer to the “Safety Alerts” topic.

Sepanjang tahun 2019, sebanyak dua edisi BUU, dua edisi buletin MADRAC dan enam e-brosur telah diterbitkan.

Untuk maklumat berkaitan isu-isu keselamatan berkaitan penggunaan ubat-ubatan pula, pengguna boleh merujuk kategori “Petugas Kesihatan Professional” dan rujuk di bawah topik “Amaran Keselamatan”.

Imej 32 : Berita Ubat-ubatanImej 33 : Buletin MADRAC

Image 32 : Berita Ubat-ubatan (BUU)Image 33 : MADRAC Bulletin


Imej 34 : e-Brosur

Image 34 : e-Brochure

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LAPORAN KEWANGAN

FINANCIAL REPORT


BAJET MENGURUS 2019OPERATING BUDGET 2019

Objek Am

Objek Code

Kategori

Category

Peruntukan

Allocation

(RM)

Perbelanjaan

Expenditure

Baki

Balance

RM % RM %

10000EmolumenEmolument

40,644,400.00 42,284,520.02 104.04% -1,640,120.02 -4.04%

20000Perkhidmatan dan

BekalanService & Supply

10,512,597.00 9,678,462.28 92.07% 834,134.72 7.93%

30000AsetAsset

0.00 0.00 0.00% 0 0.00%

40000Pemberian & Kenaan

TetapGift and Fixed Payment

0.00 0.00 0.00% 0 0.00%

50000Bayaran Balik Hasil

Refund17,000.00 17,000.00 100.00% 0 0.00%

JUMLAHTOTAL

51,173,997.00 51,979,982.30 101.57% (805,985.30) -1.57%

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BAJET PEMBANGUNAN 2019DEVELOPMENT BUDGET 2019

Objek Am

Objek Code

Kategori

Category

Peruntukan

Allocation

(RM)

Perbelanjaan

Expenditure

Baki

Balance

RM % RM %

050400Farmasi Regulatori

Pharmacy Regulatory51,173,997.00 51,979,982.30 101.57% (805,985.30) -1.57%

010100Pengurusan Ibu Pejabat

HQ management3,000.00 - 0.00% 3,000.00 100.00%

060200KejuruteraanEngineering

339,700.00

144,580.45 42.56% 195,119.55 57.44%

010300Kewangan

Finance 418,750.00

360,573.58

86.11% 58,176.42 13.89%

040101 (B11)

Bayaran Balik HasilRefund

010500

Teknologi Maklumat Dan Komunikasi

Information Tachnology & Communications

420,000.00 252,314.00 60.07% 167,686.00 39.93%

080400Penswastaan PSHPSH Privatization

1,688,642.00 1,628,695.55 96.45% 59,946.45 3.55%

JUMLAHTOTAL

54,044,089.00 54,366,145.88 100.60% (322,056.88) -0.60%


KUTIPAN HASIL TAHUN 2019REVENUE FOR 2019

Kod

Code

Perkara

Item

Jumlah

Total

(RM)

72199

Daftar Produk Kosmetik | Registration of Cosmetic Product 6,051,850.00

Daftar Ubat Baru | New Product Registration 2,929,300.00

Daftar Ubat Semula | Product Re-registration 2,638,200.00

Daftar Ubat Veterinar | Veteriner Product Registration 134,500.00

Daftar Ubat Semula Veterinar | Product Re-registration Veteriner 193,500.00

Perakuan Penjualan | Free Sale Certificate 288,750.00

Tukar Pemegang | Change of Holder 352,200.00

Daftar Ubat Ekspot | Export Product Registration 28,500.00

Pengkelasan | Classification 854,050.00

Tambahan Indikasi | Additional Indication 26,000.00

74299 Sewa Bangunan Lain | Building Rental 36,338.00

181101 Bayaran Balik Tahun lalu | Refund 66,389.52

75417 Hibah | Grant 7.33

77401 Akaun Amanah (APB) | APB Trust Account 640,625.60

71499

Lesen Impot Klinikal | Clinical Import License 116,000.00

Lesen Pengilang | Manufacturer License 263,100.00

Lesen Impot | Import License 230,000.00

Yuran Import Keluaran Tidak Berdaftar | Import Fee for Unregistered Item 700.00

Lesen Borong | Manufacturer’s License 547,000.00

72499

Invois APB Luar Negara | International GMP Invoice 270,500.00

Invois APB | GMP Invoice 583,800.00

Amalan Perkilangan Baik | Good Manufacturing Practice 122,600.00

Sijil APB | GMP Certificate 36,700.00

Invois BE | BE Invoice 789,000.00

Vaksin VLR | Vaccine Lot Release 143,800.00

Pelan Susun Atur Kilang | Factory Layout Plan 76,750.00

Plasma | Plasma 96,000.00

Variasi | Variation 1,354,200.00

Sijil Indikasi | Certificate of indication 96,600.00

Tukar Tapak Kilang | Change of manufacturer’s site 136,900.00

Invois Amalan Makmal Baik | Good laboratory Practice Invoice 26,000.00

73999 Jualan-Jualan Lain | Other Sales 2,745.10

JUMLAHTOTAL

19,132,605.55

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HALATUJU

THE WAY FORWARD


NPRA sentiasa mengutamakan kesihatan dan kesejahteraan orang awam. Selain NPRA, pelbagai pihak termasuk pemegang pendaftaran produk turut bertanggungjawab ke atas pemonitoran keselamatan produk yang berada di pasaran. Dengan adanya sistem farmakovigilans yang efisyen, pemantauan keselamatan ubat di pasaran dapat dijalankan dan seterusnya dapat menjamin keselamatan ubat-ubatan kepada pesakit dan pengguna.

Pemeriksaan Farmakovigilans merupakan aktiviti baru yang dirancang untuk dilaksanakan pada tahun 2021 di bawah Pelan Strategik NPRA 2021-2025. Pemeriksaan ini bertujuan untuk menilai tahap kepatuhan pihak pemegang pendaftaran produk terhadap Garis panduan Farmakovigilans.

Kepatuhan terhadap garis panduan dapat memastikan aspek keselamatan produk berdaftar di pasaran dipantau dengan teliti oleh pemegang pendaftaran produk melalui sistem farmakovigilans yang efisyen. Skop pemeriksaan farmakovigilans ini merangkumi pemantauan pelaporan kesan advers ubat dan vaksin, profil keselamatan produk, pengurusan risiko dan komunikasi keselamatan produk.

NPRA juga komited untuk membantu pemohon mengemukakan dokumen berkualiti selaras dengan pelaksanaan Amalan Penyerahan Baik. NPRA akan memulakan khidmat pemberian panduan regulatori kepada pemohon sebelum dossier dihantar melalui sistem yang dinamakan Pre-Submission Meeting (PSM). Ini untuk memastikan dokumen yang dikemukakan adalah lengkap dan mengikut garis panduan. Perkara ini secara langsung akan menambahbaik proses penilaian permohonan pendaftaran produk. Kategori produk yang dibenarkan melalui PSM ialah produk ubat baru (NCE), produk biologik (termasuk biosimilar), produk semula jadi dengan tuntutan terapeutik dan supplemen kesihatan dengan tuntutan pengurangan risiko penyakit. Tarikh pelaksanaan PSM adalah Mac 2020.

NPRA places a high priority on the public’s health and well-being. The safety monitoring of medicinal products in the market is essential and is the shared responsibility of various parties, including product registration holders (PRHs). With the existence of an effective pharmacovigilance system, the safety profiles of registered products are continuously monitored, therefore ensuring their safe use for patients and consumers.

Pharmacovigilance inspection is a new activity projected to be implemented in the year 2021 under the NPRA Strategic Plan 2021-2025. The objective of Pharmacovigilance Inspection is to assess the compliance of PRHs towards to the Malaysian Pharmacovigilance Guidelines.

Compliance towards the guidelines would ensure that the safety aspects of registered products in the Malaysian market are closely monitored by PRHs via an effective pharmacovigilance system. The scope of pharmacovigilance inspection includes the monitoring of adverse drug reactions and vaccines, assessment of product safety profiles, the management of risks and communication pertaining to product safety.

NPRA is also committed to assist the applicants in submitting quality dossier in line with the implementation of Good Submission Practice. NPRA will start providing regulatory advice to applicants prior to the dossier submission through a system called Pre-Submission Meeting (PSM). This is to ensure the dossier submitted is complete and documents provided are according to the guideline. This will directly improve the evaluation process upon receiving the application for product registration. The category of products which are allowed to go through PSM are New Chemical Entity (NCE), Biologics (including Biosimilar), natural products with therapeutic claims and health supplement product with disease-risk reduction claims. The implementation date of PSM will be March 2020.

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Internationally, NPRA is ready to move forward alongside other global counterparts in the area of medicine regulatory control by being a WHO Listed Authority. Therefore, NPRA has been participating in the self-assessment by WHO using the WHO Global Benchmarking Tool (WHO GBT) to ensure that our guidelines and work processes are up to the WHO standards and looking into the implementation of all the indicators under the WHO GBT. Our target for the upcoming WHO GBT Audit is to reach the highest level of compliance to the tool – which is to be accredited with Maturity Level 4. NPRA foresees the accreditation taking place by the year 2020 – 2021.

Di peringkat antarabangsa, NPRA bersedia untuk melangkah maju ke hadapan bersama badan regulatori antarabangsa lain dalam bidang regulatori farmaseutikal dengan menjadi WHO Listed Authority. Oleh itu, NPRA telah mengambil bahagian dalam penilaian kendiri WHO Global Benchmarking Tool (WHO GBT) untuk memastikan garis panduan dan proses kerja yang dilaksanakan memenuhi piawaian WHO dengan memastikan pelaksanaan semua indikator di dalam GBT WHO. Sasaran NPRA untuk WHO GBT Audit yang akan datang adalah untuk mencapai tahap tertinggi pematuhan terhadap WHO GBT iaitu akreditasi Maturity Level 4. NPRA menjangka akreditasi ini berlaku pada tahun 2020 - 2021.

BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY

Lot 36, Jalan Universiti,46200 Petaling Jaya,

Selangor Darul Ehsan,Malaysia

Tel: (60)3 7883 5400Fax: (60)3 7956 2924www.npra.gov.my

BAHAGIAN REGULATORI FARMASI NEGARA

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