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

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Second Edition – September 2016, revised July 2018

PREAMBLE

  • 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.

 
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DRGD Updates

List of DRGD Updates Download
List of DRGD Updates - November 2018 November 2018
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)
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  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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