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20Dec

Makluman Pelaksanaan Pemeriksaan Amalan Pengedaran Baik (AEB) Secara Jarak Jauh

13Dec

MOPI: Quality Assurance and GMP Training Program 2025

04Nov

Sesi Libat Urus antara Bahagian Regulatori Farmasi Negara (NPRA) bersama Pihak Berkepentingan (STAKEHOLDERS)

17Oct

Good Submission Practice 2.0 for Generic Medicines

10Sep

Latihan Kawalan Kualiti ke atas Bahan Mentah Herba dan Produk Semula Jadi

26Aug

NOTIS MAKLUMAN URUSAN PEMBAYARAN BANK DRAF ATAU KIRIMAN WANG BAGI PERMOHONAN PEMERIKSAAN PUSAT KAJIAN BE

07Aug

Announcement to Product Registration Holders (PRHs): Revision of Categories and Criteria for New/Additional Indication Application – A Pilot Study

24Jul

Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by National Pharmaceutical Regulatory Agency (NPRA)

18Jul

Pre-Membership Module Announcement

26Jun

Registration Application Submitted via Facilitated Registration Pathway (FRP) - FAQs

31May

Revision of timelines for variation applications of registered products [pharmaceutical products & natural and health supplement products (TMHS)] and a pilot study

15May

[CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition

05Apr

[INVITATION] SEMINAR: ISPE Online GDP Seminar : Module 2 (Validation & Self-Inspection Requirement for GDP Compliance)

05Apr

Makluman Penambahbaikan Proses Pengeluaran Lesen Mengimport / Lesen Pemborong melalui Penilaian dan Pemeriksaan Pra-Pelesenan

27Mar

Information Sharing Paper for Cosmetic Products in the 37th ASEAN Cosmetic Committee Meeting (8-9th May 2023)

15Mar

Iklan Sebut Harga Kerja-Kerja Menaiktaraf Sistem Pendingin Hawa Di Program Perkhidmatan Farmasi, Ibu Pejabat Kementerian Kesihatan Malaysia

08Feb

Bioequivalence & Ethics Committee Section Activities in 2023: At A Glance (And More)

30Jan

Laporan Kajian Kepuasan Pelanggan Luar NPRA Tahun 2023

23Jan

Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)

23Jan

Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 30 Bulan Kepada 36 Bulan

01Dec

[INVITATION] SEMINAR: ISPE Online GDP Seminar : Module 1 (QMS & Documentation)

30Aug

NPRA Updates on Reports of Kidney-Related Adverse Reactions after Consumption of Oral Aloe vera-Containing Products

01Aug

Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu Comirnaty Kepada 24 Bulan

31Jul

Screening Checklist for Generic Medicines (Prescription-Full)

25Jul

Pemakluman Penamatan Aktiviti Pemantauan Dan Pengemaskinian Rekod Paras Stok Produk Berdaftar

26Jun

Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu EVUSHELD Daripada 18 Bulan Kepada 24 Bulan

13Apr

Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu Paxlovid Daripada 18 Bulan Kepada 24 Bulan

13Apr

[INVITATION] SEMINAR: ISPE Malaysia Education Series: Strengthening GDP Fundamentals

04Apr

An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022

03Apr

NPRA Customer Satisfaction Survey

10Mar

Declaration of Worldwide Registration Status for Generic Medicines in QUEST System

08Mar

Change of Venue for the National Regulatory Conference (NRC) 2023 to M Resort & Hotel, Kuala Lumpur

10Jan

Pemakluman Permohonan Pertukaran Masuk Pegawai Farmasi KKM ke NPRA [kemaskini 10.01.2023]

29Dec

Bioequivalence & Ethics Committee Section Activities in 2022: At A Glance

16Dec

Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral Covid-19 Iaitu Lagevrio 200mg Hard Capsule Daripada 24 Bulan Kepada 30 Bulan

02Dec

MOPI Training -Virtual Good Manufacturing Training Program 2023

23Nov

Laporan Kajian Kepuasan Pelanggan (Luar) NPRA Tahun 2022

16Nov

Pengemaskinian Tempoh Jangka Hayat Vaksin Comirnaty (Adult dose) daripada 12 Bulan kepada 15 Bulan

07Nov

Temporary Solution for Java Security Login Problem

26Oct

Pengemaskinian Tempoh Jangka Hayat Antiviral Covid-19 Iaitu Paxlovid Daripada 12 Bulan Kepada 18 Bulan

27Sep

Publication of Revised PIC/S Annex 1

02Sep

Penarikan Balik Syarat Pendaftaran Khas Bagi Vaksin COVID-19: Hanya Boleh Dijual Atau Dibekal Kepada Pihak Kerajaan Atau Pihak Yang Diberi Kebenaran Oleh Kerajaan Sahaja

08Aug

Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2021

04Aug

Pengemaskinian Tempoh Jangka Hayat Vaksin Covid-19 (COMIRNATY & Coronavac)

28Jul

Anugerah Pekerja Cemerlang Bulanan Bahagian Regulatori Farmasi Negara (NPRA)

28Jul

Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.1 (July 2022)

18Jul

Pekeliling Berkenaan Pengemaskinian Garis Panduan Malaysian Variation Guideline for Pharmaceutical Products

15Jun

Pemakluman Permohonan Pertukaran Masuk Pegawai Farmasi KKM ke NPRA

24May

Perlaksanaan Pemeriksaan Regulatori Dalam dan Luar Negara Secara Lapangan ('On-Site') oleh Bahagian Regulatori Farmasi Negara (NPRA)

23May

Cold Chain Facilities List

27Apr

Refund Procedure Involving Online Payment Made Via National Pharmaceutical Regulatory Agency QUEST3+ System

29Mar

Voluntary Good Pharmacovigilance Practices (GVP) Inspection on Pharmaceutical Product Registration Holders (PRHs)

25Feb

Regulatory Control of Medicinal Gases

04Feb

Rejection of BE Studies Conducted at the BE Centre Micro Therapeutic Labs Following Inspection Findings by The European Medicines Agency (EMA)

31Jan

NPRA Customer Satisfaction Survey 2022

26Jan

Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022

05Jan

MOPI Training -Virtual Good Manufacturing Training Program 2022

29Dec

Issues on Accessing QUEST3+ with Avast Antivirus

21Dec

Direktif Untuk Menerima Permohonan Kebenaran Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) Bagi Produk Vaksin COVID-19 Keluaran Pengilang Tempatan Yang Menjalankan Penyelidikan dan pembangunan (R&D) di Malaysia Yang Melibatkan Kajian First-in-Human (FIH)

29Nov

Rejection of Bioequivalence (BE) Studies Conducted at The BE Centres Synchron Research Services and Panexcell Clinical Lab Following Inspection Findings by The United States Food and Drug Administration (US FDA)

25Nov

Natural Products Pre-Registration Test

25Nov

Pembaharuan Notifikasi Kosmetik

23Nov

Pembatalan Arahan Bilangan 26 Tahun 2017 : Direktif Pindaan Had Harian Pengambilan Menthol Dalam Persediaan Oral

05Nov

Direktif Berkenaan Keperluan Mendaftar Penyelidikan Klinikal Sukarelawan Sihat Dengan National Healthy Research Volunteer Register (NHRVR) Kepada Sponsor/Pemohon/Penyelidik Yang Memohon Lesen Import Percubaan Klinikal (CTIL) Dan Kelulusan Mengilang (CTX)

15Oct

Direktif untuk semua produk yang mengandungi anastrozole: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko depression

15Oct

Direktif untuk semua produk yang mengandungi bortezomib: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Guillain-Barré syndrome dan demyelinating polyneuropathy

15Oct

Direktif untuk semua produk yang mengandungi mycophenolate (mycophenolate mofetil dan mycophenolic acid): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko de novo purine synthesis inhibitors-associated acute inflammatory syndrome

15Oct

Direktif untuk semua produk yang mengandungi insulin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko cutaneous amyloidosis

04Oct

Pusat Pengambilan Permit / Sijil / Lesen Setempat Di NPRA

27Sep

Permit / Certificate / Licence Collection Hub

27Sep

Pre Submission Meeting (PSM) Guidance Document

17Sep

Voluntary Registration of Surface Disinfectants

15Sep

Invitation to becoming NPRA's Panel Labs

09Sep

Awareness On Quality Control Testing Of Herbal Raw Materials For Natural Product Workshop

06Sep

Pekeliling Berkenaan Pengeluaran Dua (2) Garis Panduan Farmakovigilans

06Sep

HSA-NPRA Generic Medicines Work Sharing Initiative

19Aug

Pemeriksaan Amalan Perkilangan Baik (APB) Dalam dan Luar Negara oleh Bahagian Regulatori Farmasi Negara (NPRA) Semasa Pandemik COVID-19

27Jul

Senarai produk tidak berdaftar/berdaftar tetapi tidak dipasarkan yang diperlukan untuk rawatan pesakit

23Jul

Direktif untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, First Revision July 2021

14Jun

Direktif untuk semua produk yang mengandungi Ceftriaxone: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko encephalopathy

25May

Awareness and Training on Quality Control in Herbal Raw Materials for Natural Product Manufacturing

20May

Garis Panduan Pengiktirafan Makmal Swasta Oleh Bahagian Regulatori Farmasi Negara (Npra) Bagi Perkhidmatan Analisis Produk Tradisional

05May

NPRA Annual Report 2020

28Apr

Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia

14Apr

Direktif untuk semua produk yang mengandungi mengandungi Mirtazapine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko amnesia dan Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

14Apr

Direktif untuk semua produk yang mengandungi Rocuronium: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Kounis Syndrome

14Apr

Direktif untuk semua produk yang mengandungi Vascular Endothelial Growth Factor (VEGF) Inhibitors untuk kegunaan sistemik (kecuali kegunaan pada mata): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko artery dissections dan aneurysms

14Apr

Direktif berkenaan pendaftaran bersyarat secara recognition berdasarkan WHO Emergency Use Listing (EUL) bagi Vaksin COVID-19 di bawah COVAX Facility

23Mar

MOPI Training -Virtual Good Manufacturing Training Program 2021

19Feb

Keputusan Pihak Berkuasa Kawalan Dadah (PBKD) Berkenaan Pengecualian Daripada Keperluan Menjalankan Ujian Fizikal Untuk Aktiviti Lot Release Bagi Semua Produk Vaksin COVID-19 Berdaftar Yang Diimport dan Digunakan Semasa Situasi Pandemik

11Feb

Direktif Berkenaan Pengukuhan Pelaksanaan Kawalan Regulatori Ke Atas Produk - Produk Gas Perubatan Dan Penggunaan Guideline On Registration Of Medicinal Gases

11Feb

Pekeliling Berkenaan Pelaksanaan Prosedur Kerja Penilaian Desktop Bagi Aktiviti Pemeriksaan Amalan Perkilangan Baik (APB) Ke Atas Premis Pengilang Farmaseutikal Luar Negara

29Jan

Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, January 2021

31Dec

Guidelines on Conditional Registration for New Chemical Entities and Biologics - 2nd Edition

22Dec

NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products

08Dec

Pekeliling Berkenaan Keperluan Pengujian Impuriti Nitrosamine Bagi Produk Yang Mengandungi Angiotensin II Receptor Blockers (ARB), Ranitidine dan Metformin

18Aug

Membership & Token

Online Public Engagement

28Jul

Online Public Engagement

16Jul

e-ENGAGEMENT SESSION: PHASES OF IMPLEMENTATION OF ROUTINE GOOD DISTRIBUTION PRACTICE (GDP) INSPECTION ON IMPORTER AND WHOLESALER OF COLD CHAIN PRODUCT / TIME & TEMPERATURE SENSITIVE PRODUCT (TTSP)

13Jul

Pekeliling Berkenaan Pengemaskinian MiV-N Do & Tell Untuk Produk Farmaseutikal, Suplemen Kesihatan Dan Produk Semulajadi

01Jul

[Update] MOPI Training -Virtual Good Manufacturing Training Program 2020

17Jun

Update on Guidance Notes for API Information for Product Registration - Version 5.0 (June 2020)

10Apr

Perlaksanaan Perintah Kawalan Pergerakan Di Premis NPRA / Implementation Of Movement Control Order In NPRA

30Mar

MADRAC Bulletin - 03/2019 Edition

09Mar

NOTIFIKASI PENGAKTIFAN FUNGSI PENGIMBASAN POINTER (PTR) RECORD DAN SENDER POLICY FRAMEWORK (SPF) RECORD DI PERINGKAT EMAIL SECURITY GATEWAY (ESG) MyGovUC

03Mar

MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:3/3/2020]

14Feb

PART 2: NPRA REGULATORY UPDATES 2019 - 2020

16Dec

Change in Administrative Procedure for Section S Revision for Registered Products (Non Anti-Infectives) with the Expiration of Registration Starting 1 January 2020

05Dec

MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:05/12/2019]

03Dec

Update of Guidance Notes for API Information for Product Registration - Version 4.0 (December 2019)

26Nov

Soalan-soalan Lazim (FAQ): Impuriti NDMA di dalam Produk Ranitidine

13Nov

Traditional, Health Supplement & Cosmetics Manufacturer: Regulatory Act upon Manufacturer with Unpaid GMP Inspection Fees

13Nov

Pharmaceutical, Radiopharmaceutical & Veterinary Products Manufacturer: Prepaid GMP Inspection Fees

13Nov

Berita Ubat-Ubatan September 2019

01Nov

NPRA Annual Report 2018

30Oct

Berita Ubat-Ubatan April 2019

15Oct

Update of Guidance Notes for API Information for Product Registration - Version 3.0 (October 2019)

23Sep

Online Registration For ASEAN ACCSQ TMHS PWG 2019

01Sep

Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020

05Aug

Manufacturer's / Importer's / Wholesaler's Licence Renewal Application for Year 2020

10Jul

Training Seminar on ICH Stability Guidelines (ICH-Q1)

10Jun

Seminar: GMP INSPECTION ON CELL AND GENE THERAPY (CGTP) FACILITIES

29May

MADRAC Bulletin - 01/2019 Edition

02May

Update of Annex 1: Requirements for Active Pharmaceutical Ingredient (API) Information during Section S Revision

16Apr

Public Consultation On Implementation Of Bioequivalence (BE) Study Requirements For New Drug Products Containing Scheduled Poison

26Mar

Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020

22Mar

Announcement Of Online Appeal Application For Product Rejected By DCA

19Mar

About myGovXchange Online Payment Service Provided by MAMPU

25Feb

Tempoh Pembayaran yang Belum Diselesaikan (Pending Payment)

25Feb

Pending Payment Expiring Period

04Feb

MOPI Training - International Good Manufacturing Training Program 2019

04Feb

Berita Ubat-Ubatan Disember 2018

31Jan

The 27th ASEAN Consultative Committee for Standards and Quality

23Jan

Verification of Translated Official Documents

07Jan

Online Payment Service Notice

12Dec

Pembukaan Data Editing dan Penutupan Data Cleaning

21Nov

Jadual Pembukaan “Section S Revision” QUEST 3+ Untuk Tujuan Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

15Nov

GMP for Cosmetics Seminar

14Nov

FAQ - QUEST ONLINE PAYMENT (Soalan Lazim - Pembayaran Atas Talian QUEST)

14Nov

FAQ - QUEST ONLINE PAYMENT

12Nov

What's new on NPRA new website

23Oct

GMP for Cosmetics Seminar

16Oct

Berita Ubat-Ubatan Jun 2018

15Oct

MADRAC Bulletin - Issue 02/2018

18Sep

Latihan TMHS – Product Quality Review (PQR) Dan Verifikasi

18Sep

Promosi Penjualan Monograf Herba Malaysia 2015

18Sep

NRC 2018 Post Conference Seminar on WHO Good Practices for Desk Assessment for Compliance with GMP / GCP /GLP

07Sep

Downloadable Forms : Generic Medicines

05Sep

2018 Education Seminar Series: Analysis of Findings from GMP Inspections of Pharmaceutical Manufacturers & Introduction to ‘Guidance Document of Pre-Approval GMP Inspection

03Sep

Submission Of Bioequvalence (BE) Study Reports For Registered Generic Products In The Form Of Effervescent, Dispersible, Orodispersible, Sublingual, Buccal And Chewable Tablets/Capsules For The Purpose Of Re-Registration (Renewal)

03Sep

Penyerahan Laporan Kajian Bioekuivalens (BE) Bagi Produk-Produk Generik Berdaftar Dalam Bentuk Effervescent, Dispersible, Orodispersible, Sublingual, Buccal Dan Chewable Tablet/Kapsul Untuk Tujuan Pendaftaran Semula [Direktif - Bil (27) dlm BPFK/PPP/07/25

07Aug

Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

07Aug

Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

30Jul

New Publication: MADRAC Bulletin - Issue 01/2018

13Jul

Penipuan Kutipan Derma

12Jul

Announcement - Prescription

16May

Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD)

16May

Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD)

01May

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

13Apr

2018 Education Seminar Series: Good Distribution Practice (GDP)

13Apr

Berita Ubat-ubatan : December 2017, Volume 70

13Apr

Berita Ubat-ubatan : September 2017, Volume 69

09Apr

National Regulatory Conference (NRC) 2018

05Apr

Latihan untuk Industri: Pemeriksaan APB Pengilang Veterinar

05Apr

MAKLUMAN SCAM PANGGILAN TELEFON

05Apr

MAKLUMAN SCAM PANGGILAN TELEFON

23Mar

New Safety Alerts for Healthcare Professionals

19Mar

QUEST3+ System USB token package

13Mar

Check Addresses Registered Under Company To Ensure There Is No Duplicated Address Or Inactive Address

07Mar

Updates on Foreign GMP Regulatory Inspection 2019

06Mar

Application Of Combination Pack (Combo Pack)

12Feb

Gentle Reminder! Application For Product Registration

12Feb

Malaysian Herbal Monograph 2015

06Feb

Berita Ubat-ubatan : Jun 2017

06Feb

Berita Ubat-ubatan : Mac 2017

26Jan

QUEST3+ System Security Upgrade

26Jan

Reminder For Successful Payment Status

16Jan

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

16Jan

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

11Jan

Update on E.13 Field for Approved Product

05Jan

Pelancaran Modul FEO ( For Export Only ) di Sistem QUEST3+

03Jan

Lanjutan Tarikh Pelaksanaan Pemakaian Guideline For Regsitration Of Drug-Medical Device And Medical Device-Drug Combination Products

26Dec

Makluman Penutupan Kaunter Kutipan Dan Terimaan Hasil Berikutan Penutupan Akaun Utama Pada 28 Dis 2017 Hingga 5 Januari 2018.

18Dec

Proses Pendaftaran Pengguna Untuk Sistem Pendaftaran Produk & Perlesenan QUEST 3+

06Dec

MOPI Training - International Good Manufacturing Training Program 2018

29Nov

Surat Peringatan Pendaftaran Semula Produk

29Nov

Surat Peringatan Pendaftaran Semula Produk

27Nov

Penutupan Pembayaran Online untuk Sistem QUEST3+ bagi Penutup Tahun 2017

23Nov

Panggilan Sesi Dialog Perbincangan Draf Garis Panduan Amalan Pengedaran Baik (AEB) Edisi Ketiga, 2018

20Nov

Pembukaan Section S & E13 untuk Variation

20Nov

Variation Open for Section E13 & Section S

15Nov

Jadual Tempoh Permohonan & Tempoh Kemaskini Bagi Data Cleaning

09Nov

Enable Export Button Using Google Chrome

09Nov

Data Cleaning Open for Approved Products Submit Manually

08Nov

Workflow For Manual Registration Of For Export Only (FEO) Products

06Nov

Workflow For Manual Registration Of For Export Only (FEO) Products

01Nov

Seranta Awam Draf Garis Panduan Amalan Pengedaran Baik, Edisi ke-3, 2018

02Oct

ISPE Malaysia - GMP/GDP Inspection on Biopharmaceuticals 2017

25Sep

Pelaksanaan Proses Kerja Baharu Pemeriksaan Rangkaian Sejuk Bagi Aktiviti Vaccine dan Plasma Product Lot Release di Malaysia

15Sep

Penutupan Sistem Lama QUEST3

08Sep

Seminar RTC Kawalan Ubat-ubatan Tradisional dan Kosmetik Bernotifikasi 2017 (Zon Sarawak )

07Sep

Penutupan Sistem QUEST3

18Aug

Cleanroom Behaviour Course

16Aug

Pengumuman Mengenai Kawalan Produk Persediaan Parenteral Sebagai Racun Di Bawah Akta Racun 1952

10Aug

Gentle Reminder: Renewal Of Product Registration

26Jul

Pemakluman Berkenaan Parking Pelawat

16Jun

Migrasi Data Berperingkat untuk Sistem QUEST3+

08May

Pengumuman Berkenaan Penghantaran Borang Beserta Pembayaran Bagi Pengkelasan, Pendaftaran Produk Untuk Tujuan Eksport (FEO), Sijil Indikasi, Sijil Deklarasi

03May

Seranta Awam Cadangan Pindaan Peraturan-peraturan Kawalan Dadah & Kosmetik 1984 (PKDK 1984)

25Apr

Updates on Bioequivalence (BE) Webpage

05Apr

PINDAAN - Seminar RTC Kawalan Ubat Tradisional dan Produk Kosmetik 2017

31Mar

Pengumuman Mengenai Penguatkuasaan Yuran Pemprosesan Permohonan Variasi Produk Pada 1 April 2017

31Mar

Pengumuman Mengenai Penguatkuasaan Yuran Pemprosesan Permohonan Variasi Produk Pada 1 April 2017

13Mar

Hari Bersama Pelanggan Bahagian Regulatori Farmasi Negara (NPRA) 2017

27Feb

Cosmetic Seminar 2017 - 28th-29th MARCH 2017

10Feb

Pengumuman : Permohonan Pendaftaran Semula, Pertukaran Pemegang Pendaftaran dan Certificate of Pharmaceutical Product (CPP) Secara Atas Talian Melalui Sistem Quest 3+

07Feb

Pemberitahuan: Permohonan Lesen Pengilang, Lesen Mengimport, Lesen Pemborong, Senarai Tambahan Produk, Sijil APB dan Pemeriksaan APB Bukan Rutin Secara Perkhidmatan Dalam Talian Menggunakan Sistem Quest3+

03Feb

Awasi Produk Tidak Berdaftar

30Dec

Penutupan Penerimaan Pendaftaran Secara Manual

28Dec

Berita Ubat-ubatan : Disember 2016

20Dec

Makluman Penutupan Kaunter Unit Hasil NPRA

16Dec

Pra Pelancaran Sistem QUEST3+ ( Modul Produk Farmaseutikal ) - CLOSED

16Dec

User Manual QUEST3+ System

14Dec

MOPI GMP Training 2017

07Dec

Laporan Tahunan NPRA 2015

25Nov

Seminar: ASEAN Common Technical Dossier (ACTD) Preparation:Generic Products for Malaysian Submission

09Sep

Seminar: Foreign GMP Regulatory Inspection & Managing Changes of Licensed Facility

07Sep

Malaysian Pharmacovigilance Guidelines 2nd Edition

30Aug

B2B Online Payment Transaction Flow

01Aug

Pelancaran Modul Kosmetik Notifikasi Quest3+

28Jul

Gangguan Talian Telefon Utama NPRA

27Jul

User Manual for QUEST3+ Digital Certificate

20Jul

Pemberitahuan Nama BPFK Untuk Bank Deraf / Kiriman Wang / Wang Pos

30Jun

Penangguhan Pelancaran QUEST3+

30Jun

Penangguhan Pelancaran QUEST3+

15Jun

Latihan ISPE TMHS & Kosmetik 2.0

11May

Pengumuman Tempoh Akhir Mengemukakan Dokumen Bagi Permohonan baru dan Variasi Pendaftaran Produk sempena Moratorium Sistem QUEST

05May

Slides for Taklimat QUEST3+ untuk Industri (26 April 2016)

28Apr

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam bentuk dos oral berkuatkuasa 1 JULAI 2016

22Mar

Format Laporan Tindakan Pembetulan dan Tindakan Pencegahan (CAPA) dan Nota Penerangan Format Laporan CAPA

01Mar

Latihan ISPE TMHS dan Kosmetik

26Feb

Slides for Regulatory Updates 2016

05Feb

Online Adverse Drug Reaction (ADR) Reporting Interruption

22Jan

Good Distribution Practice (GDP) For Transporters

22Jan

Perintah Cukai Barang dan Perkhidmatan (Pembekalan Berkadar Sifar) (Pindaan) (No.2) 2015

18Jan

International Good Manufacturing Practice Training Program 2016 (updated 18 Jan 2016)

15Jan

PERINGATAN: Tarikh Perlaksanaan Kawalan Regulatori API untuk Permohonan Baru Produk Generik yang Mengandungi Racun Berjadual bagi Produk dalam Bentuk Dos Oral Berkuatkuasa 1 JULAI 2016

04Jan

List of Cosmetic Manufacturer in Malaysia that conforms to the requirement of Good Manufacturing Practices (GMP) in accordance to the ASEAN Guideline for Cosmetic Good Manufacturing Practice

02Dec

Vaccine Lot Release: Panduan Bayaran Yuran dan Slaid Pembentangan

23Nov

New Publication: REAKSI Drug Safety News September 2015

19Oct

QUEST System Compatibility Issue

09Oct

Notice: Preventive Maintenance Works for Digicert Online System

01Oct

QUEST System Direct Links

30Sep

New Publication : Reaksi Drug Safety News May 2015

14Aug

Notice: Service Interruption for Digicert Online System on 16 August 2015

10Aug

Seminar RTC Kawalan Ubat Tradisional dan Produk Kosmetik 2015 (Zon Sarawak)

10Aug

P02 (P) An European Perspective On Orphan Medicinal Products (Bruno Sepodes, August 2015)

10Aug

Presentation Slides for Day 3 National Regulatory Conference (NRC) 2015

10Aug

Presentation Slides for Day 2 National Regulatory Conference (NRC) 2015

10Aug

Presentation Slides for Day 1 National Regulatory Conference (NRC) 2015

05Aug

Spesifikasi Baru untuk Ujian Kontaminasi Mikrobial

05Aug

Maklumat Lanjutan Tentang Spesifikasi Baru Untuk Ujian Kontaminasi Mikrobial

05Aug

Pelancaran Modul Penilaian Penuh QUEST3

05Aug

Keperluan Penetapan Had Lovastatin dari Sumber Asli dalam Produk Semulajadi

05Aug

Pelancaran Fasa Kedua Sistem QUEST3

05Aug

Pelancaran Fasa Ketiga Sistem QUEST3

05Aug

Senarai Produk Kesihatan Yang Dicampur Palsu Dengan Racun Terkawal

05Aug

Slid Pembentangan bagi Taklimat Ringkas Berkenaan Quest 3 Modul CTIL & CTX

05Aug

Garispanduan Pendaftaran Produk Homeopati

05Aug

Guildelines on Good Distribution Practice (GDP)

05Aug

Produk Dengan Nama, Tuntutan Dan Kegunaan Untuk Melansingkan Badan Tidak Dikelaskan Sebagai Produk Kosmetik

05Aug

Penggunaan Doktor Gigi Di Dalam Iklan-Iklan Produk Pergigian

05Aug

Regulatory Control of Active Pharmaceutical Ingredients

05Aug

Keperluan Mengemukakan Dokumen Sokongan Pengesahan Tahap Pencemaran Radioaktif Bagi Produk Yang Diimport Dari Negara Jepun

05Aug

Updated news on BE

05Aug

Pengeluaran Sijil APB Pengilang Kosmetik Kepada Negara ASEAN

05Aug

News on Data Exclusivity

04Aug

Panduan Pelaporan Aduan Produk Berdaftar Dengan Pihak Berkuasa Kawalan Dadah dan Pelaporan Kesan Advers (ADR)

04Aug

The 14th Meeting of the ASEAN TMHS Scientific Committee (ATSC) and Related Meetings of the ACCSQ TMHS PWG Task Force

04Aug

Classification of Medical Device-Drug-Cosmetic Interface (MDDCI) Product

04Aug

Ulasan Laporan Akhbar : A Pharmaceutical Company in India Recalled A Cholesterol-Lowering Drug Found Containing Broken Glass Pieces

04Aug

Senarai Pengilang Veterinar Yang Telah Diperiksa dan Memenuhi Keperluan APB Minima

04Aug

Borang Permohonan Pelan Aliran Premis Pengilang (Baru/Tambahan)

04Aug

Seminar on Vetting of Medicines Advertisement

04Aug

Pelaksanaan Keperluan Sistem Air Terawat dan Pengudaraan Berpusat di Premis Pengilang Tradisional

04Aug

Communicate with our Director-General (DG) of Health Malaysia on Facebook

04Aug

National Regulatory Conference 2013 - Registration is closed

04Aug

Slides for National Regulatory Conference 2013

04Aug

Pembayaran Caj Pemeriksaan Amalan Perkilangan Baik (APB) yang Dijalankan oleh BPFK Ke Atas Pengilang Tradisional & Kosmetik Secara Pra- Bayar

04Aug

KENYATAAN TAWARAN SEBUTHARGA

04Aug

Ulasan Kepada Laporan Dalam Kenyataan Akhbar UTUSAN MALAYSIA bertarikh 19 September 2013: Pengawet Memberi Kesan Alahan

04Aug

Tawaran Sebutharga Kerja-Kerja Menaiktaraf Infrastruktur dan Pendawaian Kantin di Blok B, Biro Pengawalan Farmaseutikal Kebangsaan

04Aug

Tawaran Sebutharga Kerja-kerja Menaiktaraf Lif di Bangunan Blok A2 Biro Pengawalan Farmaseutikal Kebangsaan Kementerian Kesihatan Malaysia

04Aug

Bengkel Sehari Bersama Hempedu Bumi (Penerapan Kawalan Kualiti Dalam Bahan Mentah)

04Aug

Cosmetic Seminar Organized by CTFA in Collaboration with BPFK

03Aug

CURRENT REGULATORY SYSTEM IN OIC MEMBER STATES SURVEY FORM

03Aug

Kenyataan Tawaran Sebut Harga bagi pembekalan Consumable Items dan bahan Reagen

03Aug

21st ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group Meeting (First announcement. Further information will be provided shortly)

03Aug

Malaysian Variation Guideline for TM/HS Draft 1.3 and Presentation Slides for Training Course on Malaysian Variation Guideline for Traditional Medicine and Health Supplement Products

03Aug

Membekal 30 unit Komputer Peribadi Untuk Kegunaan Pegawai di Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Jalan Universiti, Petaling Jaya.

03Aug

List of Updates on GDP Guideline 2nd Edition 2013

03Aug

PRODUK KOSMETIK YANG DIBATALKAN NOTIFIKASI ATAS ISU CAMPURPALSU

03Aug

SEMINAR : UPDATES ON ANTI MALARIAL MEDICINES (MMV)

03Aug

21st Asean Consultative Committee for Standards and Quality (ACCSQ); Pharmaceutical Product Working Group (PPWG)

03Aug

PERKHIDMATAN SEWAAN MESIN FOTOSTAT (PENYALIN) DAN CAJ BACAAN METER BAGI TEMPOH DUA (2) TAHUN DI BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN (BPFK), KEMENTERIAN KESIHATAN MALAYSIA.

03Aug

Kerja-kerja Kecil Pusat Kawalan Kualiti di Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Jalan Universiti, Petaling Jaya, Selangor.

03Aug

Semi-Manual Submission Procedure for Applications for Registration

03Aug

CHINA PRESS : MAJUN BURUNG UNTA

31Jul

INVITATION TO THE INTERSESSIONAL MEETING OF THE ACCSQ TMHS PWG AND ITS RELATED MEETINGS, 25-29 AUG, BANGKOK, THAILAND.

31Jul

“New Publication: Reaksi Drug Safety News May 2014”

31Jul

“New Publication: Reaksi Drug Safety News July 2014”

31Jul

SLIDE PRESENTATION FOR ANALYTICAL METHOD VALIDATION AND METHOD VALIDATION SEMINAR

31Jul

New Publication: Reaksi Drug Safety News September 2014

31Jul

ISPE MALAYSIA GMP CONFERENCE, 10 & 11 February 2015 (New Dates): PROGRAMME & REGISTRATION FORM.

31Jul

New Publication: Reaksi Drug Safety News November 2014

09Jul

ISPE Malaysia GMP Conference, 10-11 February 2015: Programme & Registration Form

09Jul

Technical Error with Adverse Drug Reaction Email

09Jul

Checklist for Analytical Method Validation (Chemical and Microbiological)

09Jul

1st Malaysia-Japan Symposium

05Jan

Penguatkuasaan Keperluan Pelesenan Terhadap Premis Pengilang Tempatan Yang Mengilang Produk Veterinar di Malaysia

20Dec

Announcement 2024Seksyen Amalan Edaran Baik

Makluman Pelaksanaan Pemeriksaan Amalan Pengedaran Baik (AEB) Secara Jarak Jauh

Lanjutan daripada Read More

13Dec

Announcement 2024Looi Pui Yan

MOPI: Quality Assurance and GMP Training Program 2025

The training program consists of 5 on-line courses and 9 physical courses. These courses cover the essential principles of Quality Assurance (QA), Good Manufacturing Pra

04Nov

Announcement 2024Jauze

Sesi Libat Urus antara Bahagian Regulatori Farmasi Negara (NPRA) bersama Pihak Berkepentingan (STAKEHOLDERS)

Sesi Libat Urus antar

Read More

23Jan

Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 30 Bulan Kepada 36 Bulan

01Dec

[INVITATION] SEMINAR: ISPE Online GDP Seminar : Module 1 (QMS & Documentation)

30Aug

NPRA Updates on Reports of Kidney-Related Adverse Reactions after Consumption of Oral Aloe vera-Containing Products

01Aug

Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu Comirnaty Kepada 24 Bulan

31Jul

Screening Checklist for Generic Medicines (Prescription-Full)

25Jul

Pemakluman Penamatan Aktiviti Pemantauan Dan Pengemaskinian Rekod Paras Stok Produk Berdaftar

26Jun

Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu EVUSHELD Daripada 18 Bulan Kepada 24 Bulan

13Apr

[INVITATION] SEMINAR: ISPE Malaysia Education Series: Strengthening GDP Fundamentals

04Apr

An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022

03Apr

NPRA Customer Satisfaction Survey

10Mar

Declaration of Worldwide Registration Status for Generic Medicines in QUEST System

08Mar

Change of Venue for the National Regulatory Conference (NRC) 2023 to M Resort & Hotel, Kuala Lumpur

10Jan

Pemakluman Permohonan Pertukaran Masuk Pegawai Farmasi KKM ke NPRA [kemaskini 10.01.2023]

26Oct

Pengemaskinian Tempoh Jangka Hayat Antiviral Covid-19 Iaitu Paxlovid Daripada 12 Bulan Kepada 18 Bulan

27Sep

Publication of Revised PIC/S Annex 1

04Aug

Pengemaskinian Tempoh Jangka Hayat Vaksin Covid-19 (COMIRNATY & Coronavac)

28Jul

Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.1 (July 2022)

18Jul

Pekeliling Berkenaan Pengemaskinian Garis Panduan Malaysian Variation Guideline for Pharmaceutical Products

15Jun

Pemakluman Permohonan Pertukaran Masuk Pegawai Farmasi KKM ke NPRA

24May

Perlaksanaan Pemeriksaan Regulatori Dalam dan Luar Negara Secara Lapangan ('On-Site') oleh Bahagian Regulatori Farmasi Negara (NPRA)

23May

Cold Chain Facilities List

27Apr

Refund Procedure Involving Online Payment Made Via National Pharmaceutical Regulatory Agency QUEST3+ System

04Feb

Rejection of BE Studies Conducted at the BE Centre Micro Therapeutic Labs Following Inspection Findings by The European Medicines Agency (EMA)

31Jan

NPRA Customer Satisfaction Survey 2022

05Jan

MOPI Training -Virtual Good Manufacturing Training Program 2022

21Dec

Direktif Untuk Menerima Permohonan Kebenaran Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) Bagi Produk Vaksin COVID-19 Keluaran Pengilang Tempatan Yang Menjalankan Penyelidikan dan pembangunan (R&D) di Malaysia Yang Melibatkan Kajian First-in-Human (FIH)

29Nov

Rejection of Bioequivalence (BE) Studies Conducted at The BE Centres Synchron Research Services and Panexcell Clinical Lab Following Inspection Findings by The United States Food and Drug Administration (US FDA)

23Nov

Pembatalan Arahan Bilangan 26 Tahun 2017 : Direktif Pindaan Had Harian Pengambilan Menthol Dalam Persediaan Oral

05Nov

Direktif Berkenaan Keperluan Mendaftar Penyelidikan Klinikal Sukarelawan Sihat Dengan National Healthy Research Volunteer Register (NHRVR) Kepada Sponsor/Pemohon/Penyelidik Yang Memohon Lesen Import Percubaan Klinikal (CTIL) Dan Kelulusan Mengilang (CTX)

15Oct

Direktif untuk semua produk yang mengandungi anastrozole: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko depression

04Oct

Pusat Pengambilan Permit / Sijil / Lesen Setempat Di NPRA

27Sep

Permit / Certificate / Licence Collection Hub

27Sep

Pre Submission Meeting (PSM) Guidance Document

17Sep

Voluntary Registration of Surface Disinfectants

15Sep

Invitation to becoming NPRA's Panel Labs

09Sep

Awareness On Quality Control Testing Of Herbal Raw Materials For Natural Product Workshop

25May

Awareness and Training on Quality Control in Herbal Raw Materials for Natural Product Manufacturing

05May

NPRA Annual Report 2020

23Mar

MOPI Training -Virtual Good Manufacturing Training Program 2021

19Feb

Keputusan Pihak Berkuasa Kawalan Dadah (PBKD) Berkenaan Pengecualian Daripada Keperluan Menjalankan Ujian Fizikal Untuk Aktiviti Lot Release Bagi Semua Produk Vaksin COVID-19 Berdaftar Yang Diimport dan Digunakan Semasa Situasi Pandemik

11Feb

Direktif Berkenaan Pengukuhan Pelaksanaan Kawalan Regulatori Ke Atas Produk - Produk Gas Perubatan Dan Penggunaan Guideline On Registration Of Medicinal Gases

11Feb

Pekeliling Berkenaan Pelaksanaan Prosedur Kerja Penilaian Desktop Bagi Aktiviti Pemeriksaan Amalan Perkilangan Baik (APB) Ke Atas Premis Pengilang Farmaseutikal Luar Negara

29Jan

Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, January 2021

25Nov

Natural Products Pre-Registration Test

22Dec

NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products

08Dec

Pekeliling Berkenaan Keperluan Pengujian Impuriti Nitrosamine Bagi Produk Yang Mengandungi Angiotensin II Receptor Blockers (ARB), Ranitidine dan Metformin

28Jul

Online Public Engagement

16Jul

e-ENGAGEMENT SESSION: PHASES OF IMPLEMENTATION OF ROUTINE GOOD DISTRIBUTION PRACTICE (GDP) INSPECTION ON IMPORTER AND WHOLESALER OF COLD CHAIN PRODUCT / TIME & TEMPERATURE SENSITIVE PRODUCT (TTSP)

01Jul

[Update] MOPI Training -Virtual Good Manufacturing Training Program 2020

17Jun

Update on Guidance Notes for API Information for Product Registration - Version 5.0 (June 2020)

10Apr

Perlaksanaan Perintah Kawalan Pergerakan Di Premis NPRA / Implementation Of Movement Control Order In NPRA

30Mar

MADRAC Bulletin - 03/2019 Edition

09Mar

NOTIFIKASI PENGAKTIFAN FUNGSI PENGIMBASAN POINTER (PTR) RECORD DAN SENDER POLICY FRAMEWORK (SPF) RECORD DI PERINGKAT EMAIL SECURITY GATEWAY (ESG) MyGovUC

03Mar

MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:3/3/2020]

14Feb

PART 2: NPRA REGULATORY UPDATES 2019 - 2020

16Dec

Change in Administrative Procedure for Section S Revision for Registered Products (Non Anti-Infectives) with the Expiration of Registration Starting 1 January 2020

05Dec

MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:05/12/2019]

26Dec

Makluman Penutupan Kaunter Kutipan Dan Terimaan Hasil Berikutan Penutupan Akaun Utama Pada 28 Dis 2017 Hingga 5 Januari 2018.

18Dec

Proses Pendaftaran Pengguna Untuk Sistem Pendaftaran Produk & Perlesenan QUEST 3+

06Dec

MOPI Training - International Good Manufacturing Training Program 2018

29Nov

Surat Peringatan Pendaftaran Semula Produk

27Nov

Penutupan Pembayaran Online untuk Sistem QUEST3+ bagi Penutup Tahun 2017

23Nov

Panggilan Sesi Dialog Perbincangan Draf Garis Panduan Amalan Pengedaran Baik (AEB) Edisi Ketiga, 2018

20Nov

Pembukaan Section S & E13 untuk Variation

06Nov

Workflow For Manual Registration Of For Export Only (FEO) Products

01Nov

Seranta Awam Draf Garis Panduan Amalan Pengedaran Baik, Edisi ke-3, 2018

02Oct

ISPE Malaysia - GMP/GDP Inspection on Biopharmaceuticals 2017

25Sep

Pelaksanaan Proses Kerja Baharu Pemeriksaan Rangkaian Sejuk Bagi Aktiviti Vaccine dan Plasma Product Lot Release di Malaysia

08Sep

Seminar RTC Kawalan Ubat-ubatan Tradisional dan Kosmetik Bernotifikasi 2017 (Zon Sarawak )

07Sep

Penutupan Sistem QUEST3

18Aug

Cleanroom Behaviour Course

16Aug

Pengumuman Mengenai Kawalan Produk Persediaan Parenteral Sebagai Racun Di Bawah Akta Racun 1952

10Aug

Gentle Reminder: Renewal Of Product Registration

26Jul

Pemakluman Berkenaan Parking Pelawat

16Jun

Migrasi Data Berperingkat untuk Sistem QUEST3+

08May

Pengumuman Berkenaan Penghantaran Borang Beserta Pembayaran Bagi Pengkelasan, Pendaftaran Produk Untuk Tujuan Eksport (FEO), Sijil Indikasi, Sijil Deklarasi

03May

Seranta Awam Cadangan Pindaan Peraturan-peraturan Kawalan Dadah & Kosmetik 1984 (PKDK 1984)

25Apr

Updates on Bioequivalence (BE) Webpage

05Apr

PINDAAN - Seminar RTC Kawalan Ubat Tradisional dan Produk Kosmetik 2017

31Mar

Pengumuman Mengenai Penguatkuasaan Yuran Pemprosesan Permohonan Variasi Produk Pada 1 April 2017

13Mar

Hari Bersama Pelanggan Bahagian Regulatori Farmasi Negara (NPRA) 2017

27Feb

Cosmetic Seminar 2017 - 28th-29th MARCH 2017

10Feb

Pengumuman : Permohonan Pendaftaran Semula, Pertukaran Pemegang Pendaftaran dan Certificate of Pharmaceutical Product (CPP) Secara Atas Talian Melalui Sistem Quest 3+

07Feb

Pemberitahuan: Permohonan Lesen Pengilang, Lesen Mengimport, Lesen Pemborong, Senarai Tambahan Produk, Sijil APB dan Pemeriksaan APB Bukan Rutin Secara Perkhidmatan Dalam Talian Menggunakan Sistem Quest3+

03Feb

Awasi Produk Tidak Berdaftar

03Dec

Update of Guidance Notes for API Information for Product Registration - Version 4.0 (December 2019)

13Nov

Traditional, Health Supplement & Cosmetics Manufacturer: Regulatory Act upon Manufacturer with Unpaid GMP Inspection Fees

13Nov

Pharmaceutical, Radiopharmaceutical & Veterinary Products Manufacturer: Prepaid GMP Inspection Fees

13Nov

Berita Ubat-Ubatan September 2019

30Oct

Berita Ubat-Ubatan April 2019

15Oct

Update of Guidance Notes for API Information for Product Registration - Version 3.0 (October 2019)

23Sep

Online Registration For ASEAN ACCSQ TMHS PWG 2019

01Sep

Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020

05Aug

Manufacturer's / Importer's / Wholesaler's Licence Renewal Application for Year 2020

10Jul

Training Seminar on ICH Stability Guidelines (ICH-Q1)

10Jun

Seminar: GMP INSPECTION ON CELL AND GENE THERAPY (CGTP) FACILITIES

29May

MADRAC Bulletin - 01/2019 Edition

02May

Update of Annex 1: Requirements for Active Pharmaceutical Ingredient (API) Information during Section S Revision

16Apr

Public Consultation On Implementation Of Bioequivalence (BE) Study Requirements For New Drug Products Containing Scheduled Poison

26Mar

Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020

22Mar

Announcement Of Online Appeal Application For Product Rejected By DCA

04Feb

MOPI Training - International Good Manufacturing Training Program 2019

31Jan

The 27th ASEAN Consultative Committee for Standards and Quality

23Jan

Verification of Translated Official Documents

18Jul

Pre-Membership Module Announcement

07Nov

Temporary Solution for Java Security Login Problem

29Dec

Issues on Accessing QUEST3+ with Avast Antivirus

18Aug

Membership & Token

19Mar

About myGovXchange Online Payment Service Provided by MAMPU

25Feb

Tempoh Pembayaran yang Belum Diselesaikan (Pending Payment)

25Feb

Pending Payment Expiring Period

04Feb

Berita Ubat-Ubatan Disember 2018

07Jan

Online Payment Service Notice

12Dec

Pembukaan Data Editing dan Penutupan Data Cleaning

21Nov

Jadual Pembukaan “Section S Revision” QUEST 3+ Untuk Tujuan Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

15Nov

GMP for Cosmetics Seminar

14Nov

FAQ - QUEST ONLINE PAYMENT (Soalan Lazim - Pembayaran Atas Talian QUEST)

14Nov

FAQ - QUEST ONLINE PAYMENT

12Nov

What's new on NPRA new website

23Oct

GMP for Cosmetics Seminar

16Oct

Berita Ubat-Ubatan Jun 2018

15Oct

MADRAC Bulletin - Issue 02/2018

18Sep

Latihan TMHS – Product Quality Review (PQR) Dan Verifikasi

18Sep

Promosi Penjualan Monograf Herba Malaysia 2015

18Sep

NRC 2018 Post Conference Seminar on WHO Good Practices for Desk Assessment for Compliance with GMP / GCP /GLP

05Sep

2018 Education Seminar Series: Analysis of Findings from GMP Inspections of Pharmaceutical Manufacturers & Introduction to ‘Guidance Document of Pre-Approval GMP Inspection

03Sep

Submission Of Bioequvalence (BE) Study Reports For Registered Generic Products In The Form Of Effervescent, Dispersible, Orodispersible, Sublingual, Buccal And Chewable Tablets/Capsules For The Purpose Of Re-Registration (Renewal)

03Sep

Penyerahan Laporan Kajian Bioekuivalens (BE) Bagi Produk-Produk Generik Berdaftar Dalam Bentuk Effervescent, Dispersible, Orodispersible, Sublingual, Buccal Dan Chewable Tablet/Kapsul Untuk Tujuan Pendaftaran Semula [Direktif - Bil (27) dlm BPFK/PPP/07/25

07Aug

Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

07Aug

Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020

30Jul

New Publication: MADRAC Bulletin - Issue 01/2018

13Jul

Penipuan Kutipan Derma

16May

Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD)

16May

Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD)

01May

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

13Apr

2018 Education Seminar Series: Good Distribution Practice (GDP)

13Apr

Berita Ubat-ubatan : December 2017, Volume 70

13Apr

Berita Ubat-ubatan : September 2017, Volume 69

05Apr

Latihan untuk Industri: Pemeriksaan APB Pengilang Veterinar

05Apr

MAKLUMAN SCAM PANGGILAN TELEFON

05Apr

MAKLUMAN SCAM PANGGILAN TELEFON

23Mar

New Safety Alerts for Healthcare Professionals

19Mar

QUEST3+ System USB token package

13Mar

Check Addresses Registered Under Company To Ensure There Is No Duplicated Address Or Inactive Address

07Mar

Updates on Foreign GMP Regulatory Inspection 2019

06Mar

Application Of Combination Pack (Combo Pack)

12Feb

Gentle Reminder! Application For Product Registration

12Feb

Malaysian Herbal Monograph 2015

06Feb

Berita Ubat-ubatan : Jun 2017

06Feb

Berita Ubat-ubatan : Mac 2017

26Jan

QUEST3+ System Security Upgrade

26Jan

Reminder For Successful Payment Status

16Jan

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

16Jan

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018.

11Jan

Update on E.13 Field for Approved Product

05Jan

Pelancaran Modul FEO ( For Export Only ) di Sistem QUEST3+

03Jan

Lanjutan Tarikh Pelaksanaan Pemakaian Guideline For Regsitration Of Drug-Medical Device And Medical Device-Drug Combination Products

29Nov

Surat Peringatan Pendaftaran Semula Produk

20Nov

Variation Open for Section E13 & Section S

15Nov

Jadual Tempoh Permohonan & Tempoh Kemaskini Bagi Data Cleaning

09Nov

Enable Export Button Using Google Chrome

09Nov

Data Cleaning Open for Approved Products Submit Manually

08Nov

Workflow For Manual Registration Of For Export Only (FEO) Products

15Sep

Penutupan Sistem Lama QUEST3

31Mar

Pengumuman Mengenai Penguatkuasaan Yuran Pemprosesan Permohonan Variasi Produk Pada 1 April 2017

28Dec

Berita Ubat-ubatan : Disember 2016

20Dec

Makluman Penutupan Kaunter Unit Hasil NPRA

14Dec

MOPI GMP Training 2017

07Dec

Laporan Tahunan NPRA 2015

25Nov

Seminar: ASEAN Common Technical Dossier (ACTD) Preparation:Generic Products for Malaysian Submission

09Sep

Seminar: Foreign GMP Regulatory Inspection & Managing Changes of Licensed Facility

07Sep

Malaysian Pharmacovigilance Guidelines 2nd Edition

28Jul

Gangguan Talian Telefon Utama NPRA

20Jul

Pemberitahuan Nama BPFK Untuk Bank Deraf / Kiriman Wang / Wang Pos

30Jun

Penangguhan Pelancaran QUEST3+

15Jun

Latihan ISPE TMHS & Kosmetik 2.0

28Apr

PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam bentuk dos oral berkuatkuasa 1 JULAI 2016

22Mar

Format Laporan Tindakan Pembetulan dan Tindakan Pencegahan (CAPA) dan Nota Penerangan Format Laporan CAPA

01Mar

Latihan ISPE TMHS dan Kosmetik

26Feb

Slides for Regulatory Updates 2016

05Feb

Online Adverse Drug Reaction (ADR) Reporting Interruption

22Jan

Good Distribution Practice (GDP) For Transporters

22Jan

Perintah Cukai Barang dan Perkhidmatan (Pembekalan Berkadar Sifar) (Pindaan) (No.2) 2015

18Jan

International Good Manufacturing Practice Training Program 2016 (updated 18 Jan 2016)

15Jan

PERINGATAN: Tarikh Perlaksanaan Kawalan Regulatori API untuk Permohonan Baru Produk Generik yang Mengandungi Racun Berjadual bagi Produk dalam Bentuk Dos Oral Berkuatkuasa 1 JULAI 2016

04Jan

List of Cosmetic Manufacturer in Malaysia that conforms to the requirement of Good Manufacturing Practices (GMP) in accordance to the ASEAN Guideline for Cosmetic Good Manufacturing Practice

04Aug

Cosmetic Seminar Organized by CTFA in Collaboration with BPFK

03Aug

CURRENT REGULATORY SYSTEM IN OIC MEMBER STATES SURVEY FORM

03Aug

Kenyataan Tawaran Sebut Harga bagi pembekalan Consumable Items dan bahan Reagen

03Aug

21st ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group Meeting (First announcement. Further information will be provided shortly)

03Aug

Malaysian Variation Guideline for TM/HS Draft 1.3 and Presentation Slides for Training Course on Malaysian Variation Guideline for Traditional Medicine and Health Supplement Products

03Aug

Membekal 30 unit Komputer Peribadi Untuk Kegunaan Pegawai di Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Jalan Universiti, Petaling Jaya.

03Aug

PRODUK KOSMETIK YANG DIBATALKAN NOTIFIKASI ATAS ISU CAMPURPALSU

03Aug

SEMINAR : UPDATES ON ANTI MALARIAL MEDICINES (MMV)

03Aug

21st Asean Consultative Committee for Standards and Quality (ACCSQ); Pharmaceutical Product Working Group (PPWG)

03Aug

PERKHIDMATAN SEWAAN MESIN FOTOSTAT (PENYALIN) DAN CAJ BACAAN METER BAGI TEMPOH DUA (2) TAHUN DI BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN (BPFK), KEMENTERIAN KESIHATAN MALAYSIA.

03Aug

Kerja-kerja Kecil Pusat Kawalan Kualiti di Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Jalan Universiti, Petaling Jaya, Selangor.

03Aug

Semi-Manual Submission Procedure for Applications for Registration

03Aug

CHINA PRESS : MAJUN BURUNG UNTA

31Jul

INVITATION TO THE INTERSESSIONAL MEETING OF THE ACCSQ TMHS PWG AND ITS RELATED MEETINGS, 25-29 AUG, BANGKOK, THAILAND.

31Jul

“New Publication: Reaksi Drug Safety News May 2014”

31Jul

“New Publication: Reaksi Drug Safety News July 2014”

31Jul

SLIDE PRESENTATION FOR ANALYTICAL METHOD VALIDATION AND METHOD VALIDATION SEMINAR

31Jul

New Publication: Reaksi Drug Safety News September 2014

31Jul

ISPE MALAYSIA GMP CONFERENCE, 10 & 11 February 2015 (New Dates): PROGRAMME & REGISTRATION FORM.

31Jul

New Publication: Reaksi Drug Safety News November 2014

02Dec

Vaccine Lot Release: Panduan Bayaran Yuran dan Slaid Pembentangan

23Nov

New Publication: REAKSI Drug Safety News September 2015

19Oct

QUEST System Compatibility Issue

09Oct

Notice: Preventive Maintenance Works for Digicert Online System

01Oct

QUEST System Direct Links

30Sep

New Publication : Reaksi Drug Safety News May 2015

14Aug

Notice: Service Interruption for Digicert Online System on 16 August 2015

10Aug

Seminar RTC Kawalan Ubat Tradisional dan Produk Kosmetik 2015 (Zon Sarawak)

10Aug

P02 (P) An European Perspective On Orphan Medicinal Products (Bruno Sepodes, August 2015)

10Aug

Presentation Slides for Day 3 National Regulatory Conference (NRC) 2015

10Aug

Presentation Slides for Day 2 National Regulatory Conference (NRC) 2015

10Aug

Presentation Slides for Day 1 National Regulatory Conference (NRC) 2015

09Jul

ISPE Malaysia GMP Conference, 10-11 February 2015: Programme & Registration Form

09Jul

Technical Error with Adverse Drug Reaction Email

09Jul

Checklist for Analytical Method Validation (Chemical and Microbiological)

09Jul

1st Malaysia-Japan Symposium

04Aug

The 14th Meeting of the ASEAN TMHS Scientific Committee (ATSC) and Related Meetings of the ACCSQ TMHS PWG Task Force

04Aug

Classification of Medical Device-Drug-Cosmetic Interface (MDDCI) Product

04Aug

Ulasan Laporan Akhbar : A Pharmaceutical Company in India Recalled A Cholesterol-Lowering Drug Found Containing Broken Glass Pieces

05Aug

Spesifikasi Baru untuk Ujian Kontaminasi Mikrobial

05Aug

Maklumat Lanjutan Tentang Spesifikasi Baru Untuk Ujian Kontaminasi Mikrobial

05Aug

Pelancaran Modul Penilaian Penuh QUEST3

05Aug

Keperluan Penetapan Had Lovastatin dari Sumber Asli dalam Produk Semulajadi

05Aug

Pelancaran Fasa Kedua Sistem QUEST3

05Aug

Pelancaran Fasa Ketiga Sistem QUEST3

05Aug

Senarai Produk Kesihatan Yang Dicampur Palsu Dengan Racun Terkawal

05Aug

Slid Pembentangan bagi Taklimat Ringkas Berkenaan Quest 3 Modul CTIL & CTX

05Aug

Garispanduan Pendaftaran Produk Homeopati

05Aug

Guildelines on Good Distribution Practice (GDP)

05Aug

Produk Dengan Nama, Tuntutan Dan Kegunaan Untuk Melansingkan Badan Tidak Dikelaskan Sebagai Produk Kosmetik

05Aug

Penggunaan Doktor Gigi Di Dalam Iklan-Iklan Produk Pergigian

05Aug

Regulatory Control of Active Pharmaceutical Ingredients

05Aug

Keperluan Mengemukakan Dokumen Sokongan Pengesahan Tahap Pencemaran Radioaktif Bagi Produk Yang Diimport Dari Negara Jepun

05Aug

Updated news on BE

05Aug

Pengeluaran Sijil APB Pengilang Kosmetik Kepada Negara ASEAN

05Aug

News on Data Exclusivity

05Jan

Penguatkuasaan Keperluan Pelesenan Terhadap Premis Pengilang Tempatan Yang Mengilang Produk Veterinar di Malaysia

25Nov

Pembaharuan Notifikasi Kosmetik

04Aug

Panduan Pelaporan Aduan Produk Berdaftar Dengan Pihak Berkuasa Kawalan Dadah dan Pelaporan Kesan Advers (ADR)

04Aug

Senarai Pengilang Veterinar Yang Telah Diperiksa dan Memenuhi Keperluan APB Minima

04Aug

Borang Permohonan Pelan Aliran Premis Pengilang (Baru/Tambahan)

04Aug

Seminar on Vetting of Medicines Advertisement

04Aug

Pelaksanaan Keperluan Sistem Air Terawat dan Pengudaraan Berpusat di Premis Pengilang Tradisional

04Aug

Communicate with our Director-General (DG) of Health Malaysia on Facebook

04Aug

National Regulatory Conference 2013 - Registration is closed

04Aug

Slides for National Regulatory Conference 2013

04Aug

Pembayaran Caj Pemeriksaan Amalan Perkilangan Baik (APB) yang Dijalankan oleh BPFK Ke Atas Pengilang Tradisional & Kosmetik Secara Pra- Bayar

04Aug

KENYATAAN TAWARAN SEBUTHARGA

04Aug

Ulasan Kepada Laporan Dalam Kenyataan Akhbar UTUSAN MALAYSIA bertarikh 19 September 2013: Pengawet Memberi Kesan Alahan

04Aug

Tawaran Sebutharga Kerja-Kerja Menaiktaraf Infrastruktur dan Pendawaian Kantin di Blok B, Biro Pengawalan Farmaseutikal Kebangsaan

04Aug

Tawaran Sebutharga Kerja-kerja Menaiktaraf Lif di Bangunan Blok A2 Biro Pengawalan Farmaseutikal Kebangsaan Kementerian Kesihatan Malaysia

04Aug

Bengkel Sehari Bersama Hempedu Bumi (Penerapan Kawalan Kualiti Dalam Bahan Mentah)

03Aug

List of Updates on GDP Guideline 2nd Edition 2013

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Friday, 24 Jan 2025