IMPORTANT NOTICE

Kindly be informed that staff of National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia will be Working From Home (WFH) unless instructed otherwise.

Please be advised to contact officers via email during this period to ensure the continuity of service provided.

Main Counter and Laboratory Counter for sample submission will be opened:

Monday - Friday from 8.00 am to 5.00 pm; excluding public holidays.

Collection of Permits/Certificates/Licences from One Stop Centre are by Appointment Only. Please obtain an appointment date for above matter through email at npra@npra.gov.my .

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

For General Enquiry or QUEST System Enquiry, kindly use the Helpdesk Support at the link below:
https://quest3plus.bpfk.gov.my/front-end/helpdesk.php

Any other Public Enquiry kindly email to npra@npra.gov.my

CLICK FOR MORE INFO

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

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

19Jul

New Products Approved

14Jul

Frequently Asked Questions (FAQ) about COVID-19 Vaccine

13Jul

Direktif berkenaan pelaksanaan pendaftaran bersyarat produk farmaseutikal semasa bencana secara recognition

07Jul

Additional Indications Approved

View All Announcements

Direktif untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, First Revision July 2021
published on 2021-07-23

Senarai produk tidak berdaftar/berdaftar tetapi tidak dipasarkan yang diperlukan untuk rawatan pesakit
published on 2021-07-22

Direktif berkenaan pelaksanaan pendaftaran bersyarat produk farmaseutikal semasa bencana secara recognition
published on 2021-07-12

Guidance Note for Cell and Gene Therapy Products (CGTPs) Manufacturing Facility in Malaysia
published on 2021-07-09

Oseltamivir: Risk of haemorrhages
published on 2021-07-08

More Recent Updates

14Jun

Kenyataan Akhbar KPK 11 Jun 2021 – Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

05May

Kenyataan Akhbar KPK 4 Mei 2021 – Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

07Apr

Kenyataan Akhbar KPK 6 April 2021 – Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

View All Press Release

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

18Jan

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

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

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

IMPORTANT NOTICE

Kindly be informed that staff of National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia will be Working From Home (WFH) unless instructed otherwise.

Please be advised to contact officers via email during this period to ensure the continuity of service provided.

Main Counter and Laboratory Counter for sample submission will be opened:

Monday - Friday from 8.00 am to 5.00 pm; excluding public holidays.

Collection of Permits/Certificates/Licences from One Stop Centre are by Appointment Only. Please obtain an appointment date for above matter through email at npra@npra.gov.my .

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

For General Enquiry or QUEST System Enquiry, kindly use the Helpdesk Support at the link below:
https://quest3plus.bpfk.gov.my/front-end/helpdesk.php

Any other Public Enquiry kindly email to npra@npra.gov.my

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.

PRODUCT SEARCH

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

Consumers

Health Professionals

Industries

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

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

New Products Approved

Frequently Asked Questions (FAQ) about COVID-19 Vaccine

Direktif berkenaan pelaksanaan pendaftaran bersyarat produk farmaseutikal semasa bencana secara recognition

Additional Indications Approved

Kenyataan Akhbar KPK 11 Jun 2021 – Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

Kenyataan Akhbar KPK 4 Mei 2021 – Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

Kenyataan Akhbar KPK 6 April 2021 – Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

Directives & Circulars for Combination Products

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

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

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

DISCLAIMER

Site Last Modified

Search

Main Menu English

Choose Your Language

IMPORTANT NOTICE

Kindly be informed that staff of National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia will be Working From Home (WFH) unless instructed otherwise.

Please be advised to contact officers via email during this period to ensure the continuity of service provided.

Main Counter and Laboratory Counter for sample submission will be opened:

Monday - Friday from 8.00 am to 5.00 pm; excluding public holidays.

Collection of Permits/Certificates/Licences from One Stop Centre are by Appointment Only. Please obtain an appointment date for above matter through email at npra@npra.gov.my .

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

For General Enquiry or QUEST System Enquiry, kindly use the Helpdesk Support at the link below:https://quest3plus.bpfk.gov.my/front-end/helpdesk.php

Any other Public Enquiry kindly email to npra@npra.gov.my

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.

PRODUCT SEARCH

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

Consumers

Health Professionals

Industries

More Links

DISCLAIMER

Site Last Modified

Search

Main Menu English

Choose Your Language

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

For General Enquiry or QUEST System Enquiry, kindly use the Helpdesk Support at the link below:
https://quest3plus.bpfk.gov.my/front-end/helpdesk.php