Drug Registration Guidance Document : Second Edition – September 2016, Revised July 2019

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Drug Registration Guidance Document (DRGD) Second Edition – September 2016, Revised July 2019

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) Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
g) 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 - October 2019 October 2019
List of DRGD Updates - September 2019 Sept 2019
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised July 2019 Revised July 2019
List of DRGD Updates - February to July 2019 Feb-July 2019
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised January 2019 Revised Jan 2019
List of DRGD Updates - August to December 2018 Aug-Dec 2018
List of DRGD Updates - July 2018 July 2018
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised July 2018 Revised 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
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