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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PELAKSANAAN PERINTAH KAWALAN PERGERAKAN PEMULIHAN DI PREMIS NPRA

Sukacita dimaklumkan bahawa Bahagian Regulatori Farmasi Negara (NPRA) telah mula beroperasi di premis (kecuali kakitangan yang mendapat kelulusan dan bersebab) bermula 13 Mei 2020.
Namun, demi kebaikan bersama, mohon kerjasama semua pihak untuk mematuhi etika penjarakan sosial dan hadir berurusan secara fizikal jika perlu.

NPRA masih boleh dihubungi melalui Meja Bantuan Helpdesk support (enquiry & complaint) form.

Emel staf NPRA dan borang pertanyaan boleh diakses melalui pautan di bawah.

Direktori staf: https://www.npra.gov.my/index.php/en/about/contact-us/staff-directory-2en.html

Helpdesk support (enquiry & complaint) form: https://www.npra.gov.my/index.php/en/helpdesk-enquiry-complaints.html

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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.

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.

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

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

27Jul

Online Public Engagement

24Jul

Virtual Q&A Session: Evaluation on the Need for Study Specific Inspections for Bioequivalence (BE) Studies [Registration Closed]

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

Insulin: Risk of cutaneous amyloidosis
published on 2020-08-06

Sesi Virtual Q&A: Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian Bioekuivalens (BE) [Pendaftaran Ditutup]
published on 2020-07-27

Virtual Q&A Session: Evaluation on the Need for Study Specific Inspections for Bioequivalence (BE) Studies [Registration Closed]
published on 2020-07-23

Biosimilars Approved
published on 2020-07-23

More Recent Updates

15Jul

Direktif Pemansuhan Keperluan Penghantaran Notifikasi Kajian Bioekuivalens (BE) kepada Bahagian Regulatori Farmasi Negara (NPRA)

21Jul

Direktif Pelaksanaan Penilaian Keperluan Pemeriksaan Kajian Bioekuivalens (BE)

21Jul

Pekeliling berkenaan perubahan prosedur kerja beberapa kategori variasi Minor Variation (Prior Approval) kepada Minor Variation (Notification) “Do & Tell” bagi produk farmaseutikal veterinar

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.

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

PELAKSANAAN PERINTAH KAWALAN PERGERAKAN PEMULIHAN DI PREMIS NPRA

Consumers

Health Professionals

Industries

PRODUCT SEARCH

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

Online Public Engagement

Virtual Q&A Session: Evaluation on the Need for Study Specific Inspections for Bioequivalence (BE) Studies [Registration Closed]

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

[Update] MOPI Training -Virtual Good Manufacturing Training Program 2020

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 Pemansuhan Keperluan Penghantaran Notifikasi Kajian Bioekuivalens (BE) kepada Bahagian Regulatori Farmasi Negara (NPRA)

Direktif Pelaksanaan Penilaian Keperluan Pemeriksaan Kajian Bioekuivalens (BE)

Pekeliling berkenaan perubahan prosedur kerja beberapa kategori variasi Minor Variation (Prior Approval) kepada Minor Variation (Notification) “Do & Tell” bagi produk farmaseutikal veterinar

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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