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Drug Registration Guidance Document (DRGD)

First Edition

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” Revision of December 2012.

  • 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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 NODate TITLE LATEST DRGD DRGD UPDATES
 1.    Drug Registration Guidance Document (DRGD) First Edition, revised March 2015  pdf  pdf March 2015
 2.    Drug Registration Guidance Document (DRGD) First Edition, January 2015  pdf  pdf January 2015
 3.    Drug Registration Guidance Document (DRGD) First Edition, November 2014  pdf  pdf November 2014
 4.    Drug Registration Guidance Document (DRGD) First Edition, September 2014  pdf  pdf September 2014
 5.     Drug Registration Guidance Document (DRGD) First Edition, July 2014  pdf  pdf July 2014
 6.     Drug Registration Guidance Document (DRGD) First Edition, June 2014  pdf  pdf June 2014
 7.     Drug Registration Guidance Document (DRGD) First Edition, May 2014   pdf  pdf May 2014
 8.     Drug Registration Guidance Document (DRGD) First Edition, April 2014   pdf  pdf April 2014
 9.    Drug Registration Guidance Document (DRGD) First Edition, March 2014  pdf  
 10.    Drug Registration Guidance Document (DRGD) First Edition, February 2014  pdf  pdf February 2014
 11.    Drug Registration Guidance Document (DRGD) First Edition, December  2013  pdf  pdf December 2013
 12.    Drug Registration Guidance Document (DRGD) First Edition, November  2013  pdf  pdf November 2013
 13.    New Updates on Drug Registration Guidance Document First Edition, August 2013  pdf   pdf August 2013
 14.    New Updates on Drug Registration Guidance Document First Edition, July 2013  pdf  pdf July 2013
 15.    New Updates on Drug Registration Guidance Document First Edition, June 2013  pdf  pdf June 2013
 16.    New Updates on Drug Registration Guidance Document First Edition, May 2013  pdf  
 17.    New Updates on Drug Registration Guidance Document First Edition, April 2013    pdf April 2013
 18.    Procedure for Change of Product Registration Holder is under review    
 19.    New Updates on Drug Registration Guidance Document First Edition, March 2013    pdf March 2013
 20.    New Drug Registration Guidance Document (DRGD) - effective 1st January 2013    

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