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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15Jan

NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products

08Dec

Pekeliling Berkenaan Keperluan Pengujian Impuriti Nitrosamine Bagi Produk Yang Mengandungi Angiotensin II Receptor Blockers (ARB), Ranitidine dan Metformin

27Oct

NPRA Financial Year End Closure 2020

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Additional Indications Approved
published on 2021-01-13

New Products Approved
published on 2021-01-13

Biosimilars Approved
published on 2021-01-11

List of Licensed Manufacturers in QUEST System
published on 2021-01-08

NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products
published on 2020-12-22

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23Oct

Direktif berkenaan pelaksanaan pendaftaran produk dan penguatkuasaan secara berperingkat bagi produk terapi sel dan gen (CGTPs) serta tambahan senarai produk di luar skop kawalan CGTPs oleh PBKD

15Dec

Direktif berkenaan pelaksanaan pendaftaran fast-track bersyarat untuk produk farmaseutikal semasa bencana

15Sep

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

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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

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17 Feb 2020;
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GMP – What You Need to Know

03 Mar 2020;
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Risk Management – Quality System and Process

17 Apr 2020;
07:30AM - 05:00PM
MPS National Pharmacists Convention (NPC) 2020

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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

MOPI Training -Virtual Good Manufacturing Training Program 2021

MAINTENANCE FOR PAYMENT IN QUEST3+

Guidelines on Conditional Registration for New Chemical Entities and Biologics - 2nd Edition

NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products

Pekeliling Berkenaan Keperluan Pengujian Impuriti Nitrosamine Bagi Produk Yang Mengandungi Angiotensin II Receptor Blockers (ARB), Ranitidine dan Metformin

NPRA Financial Year End Closure 2020

KENYATAAN AKHBAR KPK 23 Oktober 2020-Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

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

Direktif berkenaan pelaksanaan pendaftaran produk dan penguatkuasaan secara berperingkat bagi produk terapi sel dan gen (CGTPs) serta tambahan senarai produk di luar skop kawalan CGTPs oleh PBKD

Direktif berkenaan pelaksanaan pendaftaran fast-track bersyarat untuk produk farmaseutikal semasa bencana

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

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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