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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)

Drug REGISTRATION GUIDANCE DOCUMENT (DRGD) DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) NATIONAL PHARMACEUTICAL REGULATORY DIVISION MINISTRY OF HEALTH, malaysia Second Edition September 2016, revised January 2019 Please visit the NPRA website for the latest updates Address: Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, malaysia + 603-7883 5400 + 603-7956 2924, 7956 7075 Certified to ISO 9001:2015 Cert. No. : QMS 00894 Drug REGISTRATION GUIDANCE DOCUMENT (DRGD) National Pharmaceutical Regulatory Division, Ministry of Health malaysia . Second Edition, September 2016, Revised January 2019 2 GUIDELINE HISTORY No. Guideline Description of Amendment Effective date 1.

MINISTRY OF HEALTH, MALAYSIA ... GUIDELINE HISTORY No. Guideline Description of Amendment Effective date 1. ... GCP Good Clinical Practice GDP Good Distribution Practice GMP Good Manufacturing Practice HACCP Hazard analysis and critical control points HBsAg Surface Antigen of the Hepatitis B Virus ...

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APPENDIX 8: LIST OF PERMITTED, PROHIBITED AND …

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