National Pharmaceutical Regulatory Agency (NPRA)

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.

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

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

22Nov

New Products Approved

18Nov

Additional Indications Approved

View All Announcements

Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synchron Research Services dan Panexcell Clinical Lab Susulan Penemuan Pemeriksaan United States Food and Drug Administration (US FDA)
published on 2021-11-29

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)
published on 2021-11-29

Anastrozole: Risk of Depression
published on 2021-11-24

Pembatalan Arahan Bilangan 26 Tahun 2017 : Direktif Pindaan Had Harian Pengambilan Menthol Dalam Persediaan Oral
published on 2021-11-22

List Of GLP Compliant Test Facilities
published on 2021-11-21

More Recent Updates

17Nov

Kenyataan Akhbar KPK 16 Nov 2021 - Pemanjangan Jangka Hayat Produk Vaksin Jenis Coronavac dan Comirnaty

21Oct

Kenyataan Akhbar Produk Kosmetik Dikesan Mengandungi Racun Berjadual 21 Oktober 2021

17Sep

Kenyataan Akhbar Produk Kosmetik Dikesan Mengandungi Racun Berjadual 17 September 2021

View All Press Release

29Sep

PEKELILING BIL 2/2021 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA

20May

Directives & Circulars for Combination Products

07May

Pekeliling Bil 1 2020 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA

View All Directives & Circulars

29Nov

Anastrozole: Risk of Depression

12Oct

Bortezomib: Risk of Guillain-Barré Syndrome and Demyelinating Polyneuropathy

07Oct

Non-Vitamin K Antagonist Oral Anticoagulants (NOACs): Risk of Abnormal Uterine Bleeding

View All Safety Alerts

06 Oct 2021;
08:00AM - 05:00PM
Awareness On Quality Control Testing Of Herbal Raw Materials For Natural Product Workshop

05 Oct 2021;
08:00AM - 05:00PM
Awareness On Quality Control Testing Of Herbal Raw Materials For Natural Product Workshop

13 Jul 2021;
09:00AM - 12:00PM
Awareness and Training on Quality Control in Herbal Raw Materials for Natural Product Manufacturing

26 Apr 2021;
09:30AM - 11:00AM
ISPE Malaysia 2021 Webinar Series: Preparing for a Successful Remote Audit or Desktop Assessment

View Full Calendar