As NPRA's mission is to safeguard the nation's health,

NPRA has kept up to date with current situations and provide guidance for during CMCO and for this pandemic period.

IMPORTANT NOTICE

Kindly be informed that staff of National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia will be on duty using a rotation schedule.
Please be advised to contact officers via email during this period to ensure the continuity of service provided.

Please find the staff directory link below:
https://www.npra.gov.my/index.php/en/about/contact-us/staff-directory-2en.html

You may also contact via Public Enquiry using Helpdesk Support at the link below:
https://quest3plus.bpfk.gov.my/front-end/helpdesk.php

NPRA mission is to safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

PRODUCT SEARCH

Check product status including pharmaceutical, natural & cosmetic products.

Product Search

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

To report a suspected side effect or adverse drug reaction (ADR) to any medicine or vaccine

Report ADR as Consumers

Report ADR as Health Care Professional

Consumers

ConSERF, AEFI Reporting, RiMUP, Product Cancellation & etc

Health Professionals

Safety Alert, Reporting ADR, MADRAC, Product Complaints, Publications

Industries

Product Registration, QUEST3+ System, Guideline Central, Application Forms, FAQs.

ANNOUNCEMENTS
RECENT UPDATES
PRESS RELEASE
DIRECTIVES & CIRCULARS
SAFETY ALERTS
CALENDAR ACTIVITIES

01Mar

KAJIAN KEPUASAN PELANGGAN NPRA TAHUN 2021 (NPRA CUSTOMER SATISFACTION SURVEY YEAR 2021)

01Mar

Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.0 (March 2021)

25Feb

Frequently Asked Questions (FAQ) about Comirnaty COVID-19 Vaccine

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

View All Announcements

Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.0 (March 2021)
published on 2021-03-01

List of Licensed Manufacturers in QUEST System
published on 2021-03-01

List of Licensed Wholesalers in QUEST System
published on 2021-03-01

List of Licensed Importers in QUEST System
published on 2021-02-28

Frequently Asked Questions (FAQ) about Comirnaty COVID-19 Vaccine
published on 2021-02-25

More Recent Updates

29Jan

Kenyataan Akhbar Produk Kosmetik Dikesan Mengandungi Racun Berjadual Januari 2021

23Oct

KENYATAAN AKHBAR KPK 23 Oktober 2020-Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

15Jul

Kenyataan Akhbar KPK 15 Julai 2020 – Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

View All Press Release

18Jan

Direktif untuk semua produk yang mengandungi oseltamivir: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko thrombocytopenia

18Jan

Direktif untuk semua produk yang mengandungi ondansetron: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko kecacatan kelahiran (birth defects) susulan penggunaan ketika hamil

18Jan

Direktif untuk semua produk yang mengandungi efavirenz (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko late onset neurotoxicity

View All Directives & Circulars

26Nov

Retinoids: Updated measures for pregnancy prevention during retinoids use

26Nov

FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

30Oct

Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women

View All Safety Alerts

17 Apr 2020;
07:30AM - 05:00PM
MPS National Pharmacists Convention (NPC) 2020

View Full Calendar

As NPRA's mission is to safeguard the nation's health,

NPRA has kept up to date with current situations and provide guidance for during CMCO and for this pandemic period.

IMPORTANT NOTICE

PRODUCT SEARCH

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

Consumers

Health Professionals

Industries

KAJIAN KEPUASAN PELANGGAN NPRA TAHUN 2021 (NPRA CUSTOMER SATISFACTION SURVEY YEAR 2021)

Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.0 (March 2021)

Frequently Asked Questions (FAQ) about Comirnaty COVID-19 Vaccine

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

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

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

Kenyataan Akhbar Produk Kosmetik Dikesan Mengandungi Racun Berjadual Januari 2021

KENYATAAN AKHBAR KPK 23 Oktober 2020-Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

Kenyataan Akhbar KPK 15 Julai 2020 – Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

Direktif untuk semua produk yang mengandungi oseltamivir: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko thrombocytopenia

Direktif untuk semua produk yang mengandungi ondansetron: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko kecacatan kelahiran (birth defects) susulan penggunaan ketika hamil

Direktif untuk semua produk yang mengandungi efavirenz (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko late onset neurotoxicity

Retinoids: Updated measures for pregnancy prevention during retinoids use

FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women

More Links

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