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.

RESTRUCTURING OF THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY MINISTRY OF HEALTH MALAYSIA

With reference to the subject matter as above, kindly be informed that the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia will be undergoing a restructuring exercise. This restructuring exercise is estimated to take place beginning December 2019. The new structure which will be effective as of 2^nd December 2019 is attached herewith for your kind reference (refer Attachment A).

Kindly note that this restructuring exercise will involve the relocation of certain NPRA officers in accordance to the new sections / centres within the premise of NPRA. As communication via telephone may be a challenge due to this relocation process, we strongly encourage communications to be done via e-mail during this period to ensure the continuity of services provided.

QUEST3+ System Registration ProcessHow to register as a user in QUEST3+ system?

Registration for the QUEST 3+ System is simple,
and no regulatory consultant/agent* services should be required

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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

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

07Feb

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

04Feb

PEKELILING BERKENAAN PENDAFTARAN PRODUK PEMBASMI KUMAN PADA PERMUKAAN BENDA (SURFACE DISINFECTANT) SECARA SUKARELA (VOLUNTARY REGISTRATION)

29Jan

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

View All Announcements

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
published on 2021-02-19

Guidance Document Foreign GMP Inspection, 7th Edition, March 2021
published on 2021-02-18

Safety Updates on COVID-19 Vaccine (Comirnaty®)
published on 2021-02-17

Pekeliling Berkenaan Pelaksanaan Prosedur Kerja Penilaian Desktop Bagi Aktiviti Pemeriksaan Amalan Perkilangan Baik (APB) Ke Atas Premis Pengilang Farmaseutikal Luar Negara
published on 2021-02-11

Direktif Berkenaan Pengukuhan Pelaksanaan Kawalan Regulatori Ke Atas Produk - Produk Gas Perubatan Dan Penggunaan Guideline On Registration Of Medicinal Gases
published on 2021-02-11

More Recent Updates

29Jan

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

03 Mar 2020;
08:00AM - 05:00PM
Risk Management – Quality System and Process

View Full Calendar