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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 “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 provides a summary of the revisions made to Malaysia's Drug Registration Guidance Document (DRGD). It outlines the history of the guideline from its initial publication in 1993 up to the current Third Edition, First Revision from July 2021.
Document (DRGD), Third Edition – January 2021 Major revision due to NPRA restructure on 2 December 2019 Restructuring and renumbering of the Appendices The main body of the DRGD (62 pages) and its appendices can be downloaded separately from the NPRA website for easy viewing. List of DRGD updates will be
Drug Registration Guidance Document (DRGD) Third Edition, January 2021 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.
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the latest updated version of the Drug Registration Guidance Document (DRGD) in January.
This Guideline applies to medical products in Malaysia. It serves as the reference guide for the registration process including quality control, inspection & licensing and postregistration activities of medicinal products.
