NPRA strives to ensure the safety of medicinal products through pharmacovigilance. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.[1]


Among the pharmacovigilance activities carried out by NPRA are adverse drug reaction (ADR) monitoring and screening of drug safety alerts. These activities allow identification of drug safety issues, which are reviewed in order to implement preventative measures. NPRA also communicates information on drug safety issues to healthcare professionals and the public, in our ongoing effort increase patient safety.


Reference1. WHO (2002). The Importance of Pharmacovigilance: Safety monitoring of medicinal products. pp 7-81. WHO (2002). The Importance of Pharmacovigilance: Safety monitoring of medicinal products. pp 7-8

Recent Updates, Directives & Circulars

  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Pharmacovigilance
  • Directives & Circulars Related to Pharmacovigilance

Drug Registration Guidance Document : Second Edition – September 2016, revised July 2018


  • This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products. This document will replace the “DRUG REGISTRATION GUIDANCE DOCUMENT” Second Edition, September 2016.
  • This DRGD shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing pharmaceutical and natural products for human use in Malaysia, which include but not limited to the following:

a) Sale of Drugs Act 1952;
b) Control of Drugs and Cosmetics Regulations 1984;
c) Dangerous Drugs Act 1952;
d) Poisons Act 1952;
e) Medicines (Advertisement & Sale) Act 1956;
f) Patents Act 1983;
g) Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
h) International Trade in Endangered Species Act 2008 (Act 686).
The written laws shall take precedence over this guidance document in any event of discrepancy.



DRGD Update

List of DRGD Updates Download
List of DRGD Updates - October 2018 October 2018
List of DRGD Updates - August 2018 August 2018
List of DRGD Updates - July 2018 July 2018
List of DRGD Updates - June 2018 June 2018
List of DRGD Updates - April 2018 April 2018
List of DRGD Updates - March 2018 March 2018
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised January 2018 January 2018

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email:
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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