Drug Registration Guidance Documents (DRGD) E-Book

Drug Registration Guidance Document : Second Edition – September 2016, July 2020 Revision

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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:

DRGD Updates

List of DRGD Updates	Download
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, July 2020 Revision	Revised July 2020
List of DRGD Updates - February 2020 to July 2020	Feb 2020-July 2020
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised January 2020	Revised Jan 2020
List of DRGD Updates - August 2019 to January 2020	Aug 2019-Jan 2020
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised July 2019	Revised July 2019
List of DRGD Updates - February to July 2019	Feb 2019-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 2018-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

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