General Information
Announcement ALL
Notices
Announcements by year.
Every announcement the Authority has published, filed by the year it was issued.
2026
- 7 Jul 2026 New Login Method for QUEST3+ System – MyTrustID
- 19 Jun 2026 PELAKSANAAN KAJIAN KEPUASAN PELANGGAN LUARAN PROGRAM PERKHIDMATAN FARMASI, KKM
- 27 Apr 2026 Official Launch of the NPRA GCP, GLP, BE & EC Inspection Dashboard
- 20 Apr 2026 Update Of 'Borang Permohonan Sijil Indikasi / Sijil Deklarasi Bagi Produk Berdaftar Dengan Pihak Berkuasa Kawalan Dadah'
- 14 Apr 2026 Update on Analytical Testing and Labelling Declaration Requirements for Products Containing Animal-Derived Materials
- 8 Apr 2026 Latihan Sangkutan di NPRA bagi Latihan Liberalisasi Ahli Farmasi Provisional (PRP) di bawah Bahagian Lembaga Farmasi Malaysia (BLFM): Industri Farmaseutikal Mengilang / Industri Farmaseutikal Tidak Mengilang (Sesi 01/2026)
- 10 Feb 2026 OFFICIAL ANNOUNCEMENT: NATIONAL REGULATORY CONFERENCE 2026
- 8 Jan 2026 Notis Pembersihan Data Produk Berstatus “SAVED FORM (EXPIRED)” dalam Sistem QUEST 3+
2025
- 19 Dec 2025 MOPI: Quality Assurance and GMP Training Program 2026
- 26 Nov 2025 MAKLUMAN PENUTUPAN PEMBAYARAN AKHIR TAHUN 2025
- 13 Nov 2025 PEMAKLUMAN : PEMULIHAN SISTEM QUEST3+
- 2 Sep 2025 Latihan Sangkutan PRP di NPRA 2025
- 21 Jul 2025 Bengkel Pengujian Kawalan Kualiti Bahan Mentah Herba Bagi Produk Semulajadi
- 9 Jul 2025 SURVEILLANCE AND COMPLAINTS SECTION HIGHLIGHTS OF 2024
- 23 Jun 2025 Reminder: Submission of RiMUP for Evaluation by the Pharmacovigilance Section – Single Variation Only
- 3 Jun 2025 Screening Package for New Drug Products and Biologics
- 21 May 2025 Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025
- 5 May 2025 Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2024
- 16 Apr 2025 Outcome of GVP Inspection Voluntary Phase (2023-2024): Preliminary Key Findings & Trends
- 2 Apr 2025 Submission of RiMUP for Evaluation by the Pharmacovigilance Section, PKKK
2024
- 20 Dec 2024 Makluman Pelaksanaan Pemeriksaan Amalan Pengedaran Baik (AEB) Secara Jarak Jauh
- 4 Nov 2024 Sesi Libat Urus antara Bahagian Regulatori Farmasi Negara (NPRA) bersama Pihak Berkepentingan (STAKEHOLDERS)
- 17 Oct 2024 Good Submission Practice 2.0 for Generic Medicines
- 10 Sep 2024 Latihan Kawalan Kualiti ke atas Bahan Mentah Herba dan Produk Semula Jadi
- 26 Aug 2024 NOTIS MAKLUMAN URUSAN PEMBAYARAN BANK DRAF ATAU KIRIMAN WANG BAGI PERMOHONAN PEMERIKSAAN PUSAT KAJIAN BE
- 7 Aug 2024 Announcement to Product Registration Holders (PRHs): Revision of Categories and Criteria for New/Additional Indication Application – A Pilot Study
- 24 Jul 2024 Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by National Pharmaceutical Regulatory Agency (NPRA)
- 18 Jul 2024 Pre-Membership Module Announcement
- 26 Jun 2024 Registration Application Submitted via Facilitated Registration Pathway (FRP) - FAQs
- 31 May 2024 Revision of timelines for variation applications of registered products [pharmaceutical products & natural and health supplement products (TMHS)] and a pilot study
- 15 May 2024 [CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition
- 5 Apr 2024 Makluman Penambahbaikan Proses Pengeluaran Lesen Mengimport / Lesen Pemborong melalui Penilaian dan Pemeriksaan Pra-Pelesenan
- 5 Apr 2024 [INVITATION] SEMINAR: ISPE Online GDP Seminar : Module 2 (Validation & Self-Inspection Requirement for GDP Compliance)
- 27 Mar 2024 Information Sharing Paper for Cosmetic Products in the 37th ASEAN Cosmetic Committee Meeting (8-9th May 2023)
- 8 Feb 2024 Bioequivalence & Ethics Committee Section Activities in 2023: At A Glance (And More)
- 30 Jan 2024 Laporan Kajian Kepuasan Pelanggan Luar NPRA Tahun 2023
- 23 Jan 2024 Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 30 Bulan Kepada 36 Bulan
- 23 Jan 2024 Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)
2023
- 1 Dec 2023 [INVITATION] SEMINAR: ISPE Online GDP Seminar : Module 1 (QMS & Documentation)
- 30 Aug 2023 NPRA Updates on Reports of Kidney-Related Adverse Reactions after Consumption of Oral Aloe vera-Containing Products
- 1 Aug 2023 Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu Comirnaty Kepada 24 Bulan
- 31 Jul 2023 Screening Checklist for Generic Medicines (Prescription-Full)
- 25 Jul 2023 Pemakluman Penamatan Aktiviti Pemantauan Dan Pengemaskinian Rekod Paras Stok Produk Berdaftar
- 26 Jun 2023 Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu EVUSHELD Daripada 18 Bulan Kepada 24 Bulan
- 13 Apr 2023 Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu Paxlovid Daripada 18 Bulan Kepada 24 Bulan
- 12 Apr 2023 [INVITATION] SEMINAR: ISPE Malaysia Education Series: Strengthening GDP Fundamentals
- 4 Apr 2023 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
- 3 Apr 2023 NPRA Customer Satisfaction Survey
- 10 Mar 2023 Declaration of Worldwide Registration Status for Generic Medicines in QUEST System
- 8 Mar 2023 Change of Venue for the National Regulatory Conference (NRC) 2023 to M Resort & Hotel, Kuala Lumpur
- 10 Jan 2023 Pemakluman Permohonan Pertukaran Masuk Pegawai Farmasi KKM ke NPRA [kemaskini 10.01.2023]
2022
- 29 Dec 2022 Bioequivalence & Ethics Committee Section Activities in 2022: At A Glance
- 16 Dec 2022 Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral Covid-19 Iaitu Lagevrio 200mg Hard Capsule Daripada 24 Bulan Kepada 30 Bulan
- 1 Dec 2022 MOPI Training -Virtual Good Manufacturing Training Program 2023
- 23 Nov 2022 Laporan Kajian Kepuasan Pelanggan (Luar) NPRA Tahun 2022
- 16 Nov 2022 Pengemaskinian Tempoh Jangka Hayat Vaksin Comirnaty (Adult dose) daripada 12 Bulan kepada 15 Bulan
- 7 Nov 2022 Temporary Solution for Java Security Login Problem
- 31 Oct 2022 Penutupan Akhir Tahun Kewangan NPRA 2022
- 26 Oct 2022 Pengemaskinian Tempoh Jangka Hayat Antiviral Covid-19 Iaitu Paxlovid Daripada 12 Bulan Kepada 18 Bulan
- 27 Sep 2022 Publication of Revised PIC/S Annex 1
- 2 Sep 2022 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
- 8 Aug 2022 Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2021
- 4 Aug 2022 Pengemaskinian Tempoh Jangka Hayat Vaksin Covid-19 (COMIRNATY & Coronavac)
- 28 Jul 2022 Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.1 (July 2022)
- 28 Jul 2022 Anugerah Pekerja Cemerlang Bulanan Bahagian Regulatori Farmasi Negara (NPRA)
- 18 Jul 2022 Pekeliling Berkenaan Pengemaskinian Garis Panduan Malaysian Variation Guideline for Pharmaceutical Products
- 15 Jun 2022 Pemakluman Permohonan Pertukaran Masuk Pegawai Farmasi KKM ke NPRA
- 24 May 2022 Perlaksanaan Pemeriksaan Regulatori Dalam dan Luar Negara Secara Lapangan ('On-Site') oleh Bahagian Regulatori Farmasi Negara (NPRA)
- 23 May 2022 Cold Chain Facilities List
- 27 Apr 2022 Refund Procedure Involving Online Payment Made Via National Pharmaceutical Regulatory Agency QUEST3+ System
- 29 Mar 2022 Voluntary Good Pharmacovigilance Practices (GVP) Inspection on Pharmaceutical Product Registration Holders (PRHs)
- 25 Feb 2022 Regulatory Control of Medicinal Gases
- 4 Feb 2022 Rejection of BE Studies Conducted at the BE Centre Micro Therapeutic Labs Following Inspection Findings by The European Medicines Agency (EMA)
- 31 Jan 2022 NPRA Customer Satisfaction Survey 2022
- 26 Jan 2022 Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022
- 4 Jan 2022 MOPI Training -Virtual Good Manufacturing Training Program 2022
- 2 Jan 2022 UPDATE: NPRA Financial Year End Closure 2021
2021
- 29 Dec 2021 Issues on Accessing QUEST3+ with Avast Antivirus
- 21 Dec 2021 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 Kaj
- 29 Nov 2021 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)
- 25 Nov 2021 Pembaharuan Notifikasi Kosmetik
- 25 Nov 2021 Natural Products Pre-Registration Test
- 23 Nov 2021 Pembatalan Arahan Bilangan 26 Tahun 2017 : Direktif Pindaan Had Harian Pengambilan Menthol Dalam Persediaan Oral
- 5 Nov 2021 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)
- 15 Oct 2021 Direktif untuk semua produk yang mengandungi anastrozole: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko depression
- 15 Oct 2021 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
- 15 Oct 2021 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
- 15 Oct 2021 Direktif untuk semua produk yang mengandungi bortezomib: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Guillain-Barré syndrome dan demyelinating polyneuropathy
- 10 Oct 2021 Notice: Update for Enquiry / Complaint Form
- 4 Oct 2021 Pusat Pengambilan Permit / Sijil / Lesen Setempat Di NPRA
- 27 Sep 2021 Pre Submission Meeting (PSM) Guidance Document
- 27 Sep 2021 Permit / Certificate / Licence Collection Hub
- 17 Sep 2021 Voluntary Registration of Surface Disinfectants
- 15 Sep 2021 Invitation to becoming NPRA's Panel Labs
- 9 Sep 2021 Awareness On Quality Control Testing Of Herbal Raw Materials For Natural Product Workshop
- 6 Sep 2021 Pekeliling Berkenaan Pengeluaran Dua (2) Garis Panduan Farmakovigilans
- 6 Sep 2021 HSA-NPRA Generic Medicines Work Sharing Initiative
- 19 Aug 2021 Pemeriksaan Amalan Perkilangan Baik (APB) Dalam dan Luar Negara oleh Bahagian Regulatori Farmasi Negara (NPRA) Semasa Pandemik COVID-19
- 27 Jul 2021 Senarai produk tidak berdaftar/berdaftar tetapi tidak dipasarkan yang diperlukan untuk rawatan pesakit
- 23 Jul 2021 Direktif untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, First Revision July 2021
- 14 Jun 2021 Direktif untuk semua produk yang mengandungi Ceftriaxone: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko encephalopathy
- 25 May 2021 Awareness and Training on Quality Control in Herbal Raw Materials for Natural Product Manufacturing
- 20 May 2021 Garis Panduan Pengiktirafan Makmal Swasta Oleh Bahagian Regulatori Farmasi Negara (Npra) Bagi Perkhidmatan Analisis Produk Tradisional
- 4 May 2021 NPRA Annual Report 2020
- 28 Apr 2021 Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia
- 14 Apr 2021 Direktif berkenaan pendaftaran bersyarat secara recognition berdasarkan WHO Emergency Use Listing (EUL) bagi Vaksin COVID-19 di bawah COVAX Facility
- 14 Apr 2021 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 keselam
- 14 Apr 2021 Direktif untuk semua produk yang mengandungi Rocuronium: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Kounis Syndrome
- 14 Apr 2021 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 Sym
- 22 Mar 2021 MOPI Training -Virtual Good Manufacturing Training Program 2021
- 19 Feb 2021 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
- 11 Feb 2021 Direktif Berkenaan Pengukuhan Pelaksanaan Kawalan Regulatori Ke Atas Produk - Produk Gas Perubatan Dan Penggunaan Guideline On Registration Of Medicinal Gases
- 11 Feb 2021 Pekeliling Berkenaan Pelaksanaan Prosedur Kerja Penilaian Desktop Bagi Aktiviti Pemeriksaan Amalan Perkilangan Baik (APB) Ke Atas Premis Pengilang Farmaseutikal Luar Negara
- 29 Jan 2021 Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, January 2021
- 14 Jan 2021 MAINTENANCE FOR PAYMENT IN QUEST3+
2020
- 31 Dec 2020 Guidelines on Conditional Registration for New Chemical Entities and Biologics - 2nd Edition
- 22 Dec 2020 NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products
- 8 Dec 2020 Pekeliling Berkenaan Keperluan Pengujian Impuriti Nitrosamine Bagi Produk Yang Mengandungi Angiotensin II Receptor Blockers (ARB), Ranitidine dan Metformin
- 17 Aug 2020 Membership & Token
- 27 Jul 2020 Online Public Engagement
- 16 Jul 2020 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)
- 12 Jul 2020 Pekeliling Berkenaan Pengemaskinian MiV-N Do & Tell Untuk Produk Farmaseutikal, Suplemen Kesihatan Dan Produk Semulajadi
- 1 Jul 2020 [Update] MOPI Training -Virtual Good Manufacturing Training Program 2020
- 17 Jun 2020 Update on Guidance Notes for API Information for Product Registration - Version 5.0 (June 2020)
- 10 Apr 2020 Perlaksanaan Perintah Kawalan Pergerakan Di Premis NPRA / Implementation Of Movement Control Order In NPRA
- 30 Mar 2020 MADRAC Bulletin - 03/2019 Edition
- 9 Mar 2020 NOTIFIKASI PENGAKTIFAN FUNGSI PENGIMBASAN POINTER (PTR) RECORD DAN SENDER POLICY FRAMEWORK (SPF) RECORD DI PERINGKAT EMAIL SECURITY GATEWAY (ESG) MyGovUC
- 3 Mar 2020 MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:3/3/2020]
- 14 Feb 2020 PART 2: NPRA REGULATORY UPDATES 2019 - 2020
2019
- 16 Dec 2019 Change in Administrative Procedure for Section S Revision for Registered Products (Non Anti-Infectives) with the Expiration of Registration Starting 1 January 2020
- 5 Dec 2019 MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:05/12/2019]
- 3 Dec 2019 Update of Guidance Notes for API Information for Product Registration - Version 4.0 (December 2019)
- 25 Nov 2019 Soalan-soalan Lazim (FAQ): Impuriti NDMA di dalam Produk Ranitidine
- 13 Nov 2019 Berita Ubat-Ubatan September 2019
- 13 Nov 2019 Pharmaceutical, Radiopharmaceutical & Veterinary Products Manufacturer: Prepaid GMP Inspection Fees
- 13 Nov 2019 Traditional, Health Supplement & Cosmetics Manufacturer: Regulatory Act upon Manufacturer with Unpaid GMP Inspection Fees
- 31 Oct 2019 NPRA Annual Report 2018
- 30 Oct 2019 Berita Ubat-Ubatan April 2019
- 15 Oct 2019 Update of Guidance Notes for API Information for Product Registration - Version 3.0 (October 2019)
- 23 Sep 2019 Online Registration For ASEAN ACCSQ TMHS PWG 2019
- 1 Sep 2019 Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020
- 5 Aug 2019 Manufacturer's / Importer's / Wholesaler's Licence Renewal Application for Year 2020
- 10 Jul 2019 Training Seminar on ICH Stability Guidelines (ICH-Q1)
- 10 Jun 2019 Seminar: GMP INSPECTION ON CELL AND GENE THERAPY (CGTP) FACILITIES
- 29 May 2019 MADRAC Bulletin - 01/2019 Edition
- 2 May 2019 Update of Annex 1: Requirements for Active Pharmaceutical Ingredient (API) Information during Section S Revision
- 16 Apr 2019 Public Consultation On Implementation Of Bioequivalence (BE) Study Requirements For New Drug Products Containing Scheduled Poison
- 26 Mar 2019 Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020
- 22 Mar 2019 Announcement Of Online Appeal Application For Product Rejected By DCA
- 19 Mar 2019 About myGovXchange Online Payment Service Provided by MAMPU
- 25 Feb 2019 Tempoh Pembayaran yang Belum Diselesaikan (Pending Payment)
- 25 Feb 2019 Pending Payment Expiring Period
- 4 Feb 2019 MOPI Training - International Good Manufacturing Training Program 2019
- 4 Feb 2019 Berita Ubat-Ubatan Disember 2018
- 31 Jan 2019 The 27th ASEAN Consultative Committee for Standards and Quality
- 23 Jan 2019 Verification of Translated Official Documents
- 7 Jan 2019 Online Payment Service Notice
2018
- 12 Dec 2018 Pembukaan Data Editing dan Penutupan Data Cleaning
- 21 Nov 2018 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
- 15 Nov 2018 GMP for Cosmetics Seminar
- 14 Nov 2018 FAQ - QUEST ONLINE PAYMENT
- 14 Nov 2018 FAQ - QUEST ONLINE PAYMENT (Soalan Lazim - Pembayaran Atas Talian QUEST)
- 12 Nov 2018 What's new on NPRA new website
- 23 Oct 2018 GMP for Cosmetics Seminar
- 16 Oct 2018 Berita Ubat-Ubatan Jun 2018
- 15 Oct 2018 MADRAC Bulletin - Issue 02/2018
- 18 Sep 2018 Latihan TMHS – Product Quality Review (PQR) Dan Verifikasi
- 18 Sep 2018 Promosi Penjualan Monograf Herba Malaysia 2015
- 18 Sep 2018 NRC 2018 Post Conference Seminar on WHO Good Practices for Desk Assessment for Compliance with GMP / GCP /GLP
- 7 Sep 2018 Downloadable Forms : Generic Medicines
- 5 Sep 2018 2018 Education Seminar Series: Analysis of Findings from GMP Inspections of Pharmaceutical Manufacturers & Introduction to ‘Guidance Document of Pre-Approval GMP Inspection
- 3 Sep 2018 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
- 3 Sep 2018 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)
- 7 Aug 2018 Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020
- 7 Aug 2018 Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020
- 29 Jul 2018 New Publication: MADRAC Bulletin - Issue 01/2018
- 13 Jul 2018 Penipuan Kutipan Derma
- 12 Jul 2018 Announcement - Prescription
- 16 May 2018 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)
- 16 May 2018 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)
- 30 Apr 2018 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.
- 13 Apr 2018 Berita Ubat-ubatan : September 2017, Volume 69
- 13 Apr 2018 Berita Ubat-ubatan : December 2017, Volume 70
- 13 Apr 2018 2018 Education Seminar Series: Good Distribution Practice (GDP)
- 9 Apr 2018 National Regulatory Conference (NRC) 2018
- 5 Apr 2018 MAKLUMAN SCAM PANGGILAN TELEFON
- 5 Apr 2018 Latihan untuk Industri: Pemeriksaan APB Pengilang Veterinar
- 5 Apr 2018 MAKLUMAN SCAM PANGGILAN TELEFON
- 23 Mar 2018 New Safety Alerts for Healthcare Professionals
- 19 Mar 2018 QUEST3+ System USB token package
- 13 Mar 2018 Check Addresses Registered Under Company To Ensure There Is No Duplicated Address Or Inactive Address
- 7 Mar 2018 Updates on Foreign GMP Regulatory Inspection 2019
- 6 Mar 2018 Application Of Combination Pack (Combo Pack)
- 12 Feb 2018 Malaysian Herbal Monograph 2015
- 12 Feb 2018 Gentle Reminder! Application For Product Registration
- 6 Feb 2018 Berita Ubat-ubatan : Jun 2017
- 6 Feb 2018 Berita Ubat-ubatan : Mac 2017
- 26 Jan 2018 Reminder For Successful Payment Status
- 26 Jan 2018 QUEST3+ System Security Upgrade
- 16 Jan 2018 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.
- 16 Jan 2018 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.
- 11 Jan 2018 Update on E.13 Field for Approved Product
- 11 Jan 2018 Update on E.13 Field for Approved Product
- 5 Jan 2018 Pelancaran Modul FEO ( For Export Only ) di Sistem QUEST3+
- 3 Jan 2018 Lanjutan Tarikh Pelaksanaan Pemakaian Guideline For Regsitration Of Drug-Medical Device And Medical Device-Drug Combination Products
2017
- 26 Dec 2017 Makluman Penutupan Kaunter Kutipan Dan Terimaan Hasil Berikutan Penutupan Akaun Utama Pada 28 Dis 2017 Hingga 5 Januari 2018.
- 18 Dec 2017 Proses Pendaftaran Pengguna Untuk Sistem Pendaftaran Produk & Perlesenan QUEST 3+
- 6 Dec 2017 MOPI Training - International Good Manufacturing Training Program 2018
- 29 Nov 2017 Surat Peringatan Pendaftaran Semula Produk
- 29 Nov 2017 Surat Peringatan Pendaftaran Semula Produk
- 27 Nov 2017 Penutupan Pembayaran Online untuk Sistem QUEST3+ bagi Penutup Tahun 2017
- 23 Nov 2017 Panggilan Sesi Dialog Perbincangan Draf Garis Panduan Amalan Pengedaran Baik (AEB) Edisi Ketiga, 2018
- 20 Nov 2017 Pembukaan Section S & E13 untuk Variation
- 20 Nov 2017 Variation Open for Section E13 & Section S
- 15 Nov 2017 Jadual Tempoh Permohonan & Tempoh Kemaskini Bagi Data Cleaning
- 9 Nov 2017 Data Cleaning Open for Approved Products Submit Manually
- 9 Nov 2017 Enable Export Button Using Google Chrome
- 8 Nov 2017 Workflow For Manual Registration Of For Export Only (FEO) Products
- 6 Nov 2017 Workflow For Manual Registration Of For Export Only (FEO) Products
- 1 Nov 2017 Seranta Awam Draf Garis Panduan Amalan Pengedaran Baik, Edisi ke-3, 2018
- 2 Oct 2017 ISPE Malaysia - GMP/GDP Inspection on Biopharmaceuticals 2017
- 25 Sep 2017 Pelaksanaan Proses Kerja Baharu Pemeriksaan Rangkaian Sejuk Bagi Aktiviti Vaccine dan Plasma Product Lot Release di Malaysia
- 15 Sep 2017 Penutupan Sistem Lama QUEST3
- 7 Sep 2017 Penutupan Sistem QUEST3
- 7 Sep 2017 Seminar RTC Kawalan Ubat-ubatan Tradisional dan Kosmetik Bernotifikasi 2017 (Zon Sarawak )
- 18 Aug 2017 Cleanroom Behaviour Course
- 16 Aug 2017 Pengumuman Mengenai Kawalan Produk Persediaan Parenteral Sebagai Racun Di Bawah Akta Racun 1952
- 10 Aug 2017 Gentle Reminder: Renewal Of Product Registration
- 26 Jul 2017 Pemakluman Berkenaan Parking Pelawat
- 16 Jun 2017 Migrasi Data Berperingkat untuk Sistem QUEST3+
- 8 May 2017 Pengumuman Berkenaan Penghantaran Borang Beserta Pembayaran Bagi Pengkelasan, Pendaftaran Produk Untuk Tujuan Eksport (FEO), Sijil Indikasi, Sijil Deklarasi
- 3 May 2017 Seranta Awam Cadangan Pindaan Peraturan-peraturan Kawalan Dadah & Kosmetik 1984 (PKDK 1984)
- 25 Apr 2017 Updates on Bioequivalence (BE) Webpage
- 5 Apr 2017 PINDAAN - Seminar RTC Kawalan Ubat Tradisional dan Produk Kosmetik 2017
- 31 Mar 2017 Pengumuman Mengenai Penguatkuasaan Yuran Pemprosesan Permohonan Variasi Produk Pada 1 April 2017
- 31 Mar 2017 Pengumuman Mengenai Penguatkuasaan Yuran Pemprosesan Permohonan Variasi Produk Pada 1 April 2017
- 13 Mar 2017 Hari Bersama Pelanggan Bahagian Regulatori Farmasi Negara (NPRA) 2017
- 27 Feb 2017 Cosmetic Seminar 2017 - 28th-29th MARCH 2017
- 10 Feb 2017 Pengumuman : Permohonan Pendaftaran Semula, Pertukaran Pemegang Pendaftaran dan Certificate of Pharmaceutical Product (CPP) Secara Atas Talian Melalui Sistem Quest 3+
- 6 Feb 2017 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+
- 3 Feb 2017 Awasi Produk Tidak Berdaftar
2016
- 30 Dec 2016 Penutupan Penerimaan Pendaftaran Secara Manual
- 28 Dec 2016 Berita Ubat-ubatan : Disember 2016
- 20 Dec 2016 Makluman Penutupan Kaunter Unit Hasil NPRA
- 16 Dec 2016 User Manual QUEST3+ System
- 16 Dec 2016 Pra Pelancaran Sistem QUEST3+ ( Modul Produk Farmaseutikal ) - CLOSED
- 14 Dec 2016 MOPI GMP Training 2017
- 6 Dec 2016 Laporan Tahunan NPRA 2015
- 25 Nov 2016 Seminar: ASEAN Common Technical Dossier (ACTD) Preparation:Generic Products for Malaysian Submission
- 9 Sep 2016 Seminar: Foreign GMP Regulatory Inspection & Managing Changes of Licensed Facility
- 30 Aug 2016 B2B Online Payment Transaction Flow
- 31 Jul 2016 Pelancaran Modul Kosmetik Notifikasi Quest3+
- 28 Jul 2016 Gangguan Talian Telefon Utama NPRA
- 27 Jul 2016 User Manual for QUEST3+ Digital Certificate
- 20 Jul 2016 Pemberitahuan Nama BPFK Untuk Bank Deraf / Kiriman Wang / Wang Pos
- 30 Jun 2016 Penangguhan Pelancaran QUEST3+
- 30 Jun 2016 Penangguhan Pelancaran QUEST3+
- 15 Jun 2016 Latihan ISPE TMHS & Kosmetik 2.0
- 10 May 2016 Pengumuman Tempoh Akhir Mengemukakan Dokumen Bagi Permohonan baru dan Variasi Pendaftaran Produk sempena Moratorium Sistem QUEST
- 5 May 2016 Slides for Taklimat QUEST3+ untuk Industri (26 April 2016)
- 28 Apr 2016 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
- 22 Mar 2016 Format Laporan Tindakan Pembetulan dan Tindakan Pencegahan (CAPA) dan Nota Penerangan Format Laporan CAPA
- 1 Mar 2016 Latihan ISPE TMHS dan Kosmetik
- 26 Feb 2016 Slides for Regulatory Updates 2016
- 4 Feb 2016 Online Adverse Drug Reaction (ADR) Reporting Interruption
- 22 Jan 2016 Perintah Cukai Barang dan Perkhidmatan (Pembekalan Berkadar Sifar) (Pindaan) (No.2) 2015
- 22 Jan 2016 Good Distribution Practice (GDP) For Transporters
- 18 Jan 2016 International Good Manufacturing Practice Training Program 2016 (updated 18 Jan 2016)
- 15 Jan 2016 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
- 4 Jan 2016 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
2015
- 2 Dec 2015 Vaccine Lot Release: Panduan Bayaran Yuran dan Slaid Pembentangan
- 23 Nov 2015 New Publication: REAKSI Drug Safety News September 2015
- 19 Oct 2015 QUEST System Compatibility Issue
- 9 Oct 2015 Notice: Preventive Maintenance Works for Digicert Online System
- 1 Oct 2015 QUEST System Direct Links
- 30 Sep 2015 New Publication : Reaksi Drug Safety News May 2015
- 14 Aug 2015 Notice: Service Interruption for Digicert Online System on 16 August 2015
- 10 Aug 2015 Presentation Slides for Day 1 National Regulatory Conference (NRC) 2015
- 10 Aug 2015 Presentation Slides for Day 2 National Regulatory Conference (NRC) 2015
- 10 Aug 2015 Presentation Slides for Day 3 National Regulatory Conference (NRC) 2015
- 10 Aug 2015 P02 (P) An European Perspective On Orphan Medicinal Products (Bruno Sepodes, August 2015)
- 10 Aug 2015 Seminar RTC Kawalan Ubat Tradisional dan Produk Kosmetik 2015 (Zon Sarawak)
- 5 Aug 2015 News on Data Exclusivity
- 5 Aug 2015 Pengeluaran Sijil APB Pengilang Kosmetik Kepada Negara ASEAN
- 5 Aug 2015 Updated news on BE
- 5 Aug 2015 Keperluan Mengemukakan Dokumen Sokongan Pengesahan Tahap Pencemaran Radioaktif Bagi Produk Yang Diimport Dari Negara Jepun
- 5 Aug 2015 Regulatory Control of Active Pharmaceutical Ingredients
- 5 Aug 2015 Penggunaan Doktor Gigi Di Dalam Iklan-Iklan Produk Pergigian
- 5 Aug 2015 Produk Dengan Nama, Tuntutan Dan Kegunaan Untuk Melansingkan Badan Tidak Dikelaskan Sebagai Produk Kosmetik
- 5 Aug 2015 Guildelines on Good Distribution Practice (GDP)
- 5 Aug 2015 Garispanduan Pendaftaran Produk Homeopati
- 5 Aug 2015 Slid Pembentangan bagi Taklimat Ringkas Berkenaan Quest 3 Modul CTIL & CTX
- 5 Aug 2015 Senarai Produk Kesihatan Yang Dicampur Palsu Dengan Racun Terkawal
- 5 Aug 2015 Pelancaran Fasa Ketiga Sistem QUEST3
- 5 Aug 2015 Pelancaran Fasa Kedua Sistem QUEST3
- 5 Aug 2015 Keperluan Penetapan Had Lovastatin dari Sumber Asli dalam Produk Semulajadi
- 5 Aug 2015 Pelancaran Modul Penilaian Penuh QUEST3
- 5 Aug 2015 Maklumat Lanjutan Tentang Spesifikasi Baru Untuk Ujian Kontaminasi Mikrobial
- 5 Aug 2015 Spesifikasi Baru untuk Ujian Kontaminasi Mikrobial
- 4 Aug 2015 Cosmetic Seminar Organized by CTFA in Collaboration with BPFK
- 4 Aug 2015 Bengkel Sehari Bersama Hempedu Bumi (Penerapan Kawalan Kualiti Dalam Bahan Mentah)
- 4 Aug 2015 Tawaran Sebutharga Kerja-kerja Menaiktaraf Lif di Bangunan Blok A2 Biro Pengawalan Farmaseutikal Kebangsaan Kementerian Kesihatan Malaysia
- 4 Aug 2015 Tawaran Sebutharga Kerja-Kerja Menaiktaraf Infrastruktur dan Pendawaian Kantin di Blok B, Biro Pengawalan Farmaseutikal Kebangsaan
- 4 Aug 2015 Ulasan Kepada Laporan Dalam Kenyataan Akhbar UTUSAN MALAYSIA bertarikh 19 September 2013: Pengawet Memberi Kesan Alahan
- 4 Aug 2015 KENYATAAN TAWARAN SEBUTHARGA
- 4 Aug 2015 Pembayaran Caj Pemeriksaan Amalan Perkilangan Baik (APB) yang Dijalankan oleh BPFK Ke Atas Pengilang Tradisional & Kosmetik Secara Pra- Bayar
- 4 Aug 2015 Slides for National Regulatory Conference 2013
- 4 Aug 2015 National Regulatory Conference 2013 - Registration is closed
- 4 Aug 2015 Communicate with our Director-General (DG) of Health Malaysia on Facebook
- 4 Aug 2015 Pelaksanaan Keperluan Sistem Air Terawat dan Pengudaraan Berpusat di Premis Pengilang Tradisional
- 4 Aug 2015 Panduan Pelaporan Aduan Produk Berdaftar Dengan Pihak Berkuasa Kawalan Dadah dan Pelaporan Kesan Advers (ADR)
- 4 Aug 2015 Seminar on Vetting of Medicines Advertisement
- 4 Aug 2015 Borang Permohonan Pelan Aliran Premis Pengilang (Baru/Tambahan)
- 4 Aug 2015 Senarai Pengilang Veterinar Yang Telah Diperiksa dan Memenuhi Keperluan APB Minima
- 4 Aug 2015 Ulasan Laporan Akhbar : A Pharmaceutical Company in India Recalled A Cholesterol-Lowering Drug Found Containing Broken Glass Pieces
- 4 Aug 2015 Classification of Medical Device-Drug-Cosmetic Interface (MDDCI) Product
- 4 Aug 2015 The 14th Meeting of the ASEAN TMHS Scientific Committee (ATSC) and Related Meetings of the ACCSQ TMHS PWG Task Force
- 3 Aug 2015 CHINA PRESS : MAJUN BURUNG UNTA
- 3 Aug 2015 Semi-Manual Submission Procedure for Applications for Registration
- 3 Aug 2015 Kerja-kerja Kecil Pusat Kawalan Kualiti di Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Jalan Universiti, Petaling Jaya, Selangor.
- 3 Aug 2015 PERKHIDMATAN SEWAAN MESIN FOTOSTAT (PENYALIN) DAN CAJ BACAAN METER BAGI TEMPOH DUA (2) TAHUN DI BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN (BPFK), KEMENTERIAN KESIHATAN MALAYSIA.
- 3 Aug 2015 21st Asean Consultative Committee for Standards and Quality (ACCSQ); Pharmaceutical Product Working Group (PPWG)
- 3 Aug 2015 SEMINAR : UPDATES ON ANTI MALARIAL MEDICINES (MMV)
- 3 Aug 2015 PRODUK KOSMETIK YANG DIBATALKAN NOTIFIKASI ATAS ISU CAMPURPALSU
- 3 Aug 2015 List of Updates on GDP Guideline 2nd Edition 2013
- 3 Aug 2015 Membekal 30 unit Komputer Peribadi Untuk Kegunaan Pegawai di Biro Pengawalan Farmaseutikal Kebangsaan, Kementerian Kesihatan Malaysia, Jalan Universiti, Petaling Jaya.
- 3 Aug 2015 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
- 3 Aug 2015 21st ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group Meeting (First announcement. Further information will be provided shortly)
- 3 Aug 2015 Kenyataan Tawaran Sebut Harga bagi pembekalan Consumable Items dan bahan Reagen
- 3 Aug 2015 CURRENT REGULATORY SYSTEM IN OIC MEMBER STATES SURVEY FORM
- 31 Jul 2015 New Publication: Reaksi Drug Safety News November 2014
- 31 Jul 2015 ISPE MALAYSIA GMP CONFERENCE, 10 & 11 February 2015 (New Dates): PROGRAMME & REGISTRATION FORM.
- 31 Jul 2015 New Publication: Reaksi Drug Safety News September 2014
- 31 Jul 2015 SLIDE PRESENTATION FOR ANALYTICAL METHOD VALIDATION AND METHOD VALIDATION SEMINAR
- 31 Jul 2015 “New Publication: Reaksi Drug Safety News July 2014”
- 31 Jul 2015 “New Publication: Reaksi Drug Safety News May 2014”
- 31 Jul 2015 INVITATION TO THE INTERSESSIONAL MEETING OF THE ACCSQ TMHS PWG AND ITS RELATED MEETINGS, 25-29 AUG, BANGKOK, THAILAND.
- 9 Jul 2015 1st Malaysia-Japan Symposium
- 9 Jul 2015 Checklist for Analytical Method Validation (Chemical and Microbiological)
- 9 Jul 2015 Technical Error with Adverse Drug Reaction Email
- 9 Jul 2015 ISPE Malaysia GMP Conference, 10-11 February 2015: Programme & Registration Form