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  Drug Registration Guidance Document (DRGD)
First Edition

 

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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.

 

Announcements on Drug Registration Guidance Document Updates - more...
14 Aug, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, July 2014
22 Jul, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, June 2014
17 Jun, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, May 2014
05 May, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, APRIL 2014
03 Apr, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, MARCH 2014
04 Mar, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, FEBRUARY 2014
20 Jan, 2014
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, DECEMBER 2013
27 Nov, 2013
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) FIRST EDITION, NOVEMBER 2013
06 Sep, 2013
New Updates on Drug Registration Guidance Document First Edition, AUGUST 2013
02 Aug, 2013
New Updates on Drug Registration Guidance Document First Edition, July 2013
02 Jul, 2013
New Updates on Drug Registration Guidance Document First Edition, June 2013
07 Jun, 2013
New Updates on Drug Registration Guidance Document First Edition, May 2013
02 May, 2013
New Updates on Drug Registration Guidance Document First Edition, April 2013
23 Apr, 2013
Procedure for Change of Product Registration Holder is under review
15 Apr, 2013
New Updates on Drug Registration Guidance Document First Edition, March 2013

 




 
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