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.

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.

Attachment A

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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.

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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

10Sep

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

18Aug

MEMBERSHIP & TOKEN

28Jul

Online Public Engagement

16Jul

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)

13Jul

Pekeliling Berkenaan Pengemaskinian MiV-N Do & Tell Untuk Produk Farmaseutikal, Suplemen Kesihatan Dan Produk Semulajadi

10Jul

Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Second Edition, September 2016, July 2020 Revision

View All Announcements

Guideline For Registration of Drug-Medical Device And Medical Device-Drug Combination Products 3rd Edition, 2020
published on 2020-09-23

Direktif berkenaan pindaan syarat pendaftaran khas bagi produk yang mengandungi oral retinoid yang diindikasikan untuk rawatan penyakit kulit
published on 2020-09-15

PEKELILING BERKENAAN PENDAFTARAN PRODUK PEMBASMI KUMAN PADA PERMUKAAN BENDA (SURFACE DISINFECTANT) SECARA SUKARELA (VOLUNTARY REGISTRATION)
published on 2020-09-10

List of Renewal Approved Veterinary Products
published on 2020-09-08

Additional Indications Approved
published on 2020-09-08

More Recent Updates

15Jul

Direktif berkenaan pindaan syarat pendaftaran khas bagi produk yang mengandungi oral retinoid yang diindikasikan untuk rawatan penyakit kulit

18Aug

Direktif untuk semua produk yang mengandungi propofol: Pengemaskinian sisip bungkusan dengan penambahan maklumat keselamatan berkaitan risiko priapism

18Aug

Direktif untuk semua produk parenteral nutrition yang mengandungi asid amino dan/atau lipid (yang indikasinya termasuk untuk kegunaan dalam kalangan golongan pediatrik di bawah usia dua tahun): Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan kesan advers (adverse outcomes) akibat pendedahan produk kepada cahaya semasa administrasi

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

03 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Reasoning and Decision Making

04 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Managing Change – assessing the resistance and readiness

17 Feb 2020;
08:00AM - 05:00PM
GMP – What You Need to Know

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

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.

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.

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

PRODUCT SEARCH

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

Consumers

Health Professionals

Industries

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

MEMBERSHIP & TOKEN

Online Public Engagement

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)

Pekeliling Berkenaan Pengemaskinian MiV-N Do & Tell Untuk Produk Farmaseutikal, Suplemen Kesihatan Dan Produk Semulajadi

Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Second Edition, September 2016, July 2020 Revision

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

KENYATAAN AKHBAR KPK 9 Jun 2020-Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

KENYATAAN AKHBAR KPK 25 April 2020-Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

Direktif berkenaan pindaan syarat pendaftaran khas bagi produk yang mengandungi oral retinoid yang diindikasikan untuk rawatan penyakit kulit

Direktif untuk semua produk yang mengandungi propofol: Pengemaskinian sisip bungkusan dengan penambahan maklumat keselamatan berkaitan risiko priapism

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

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