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Drug Registration Guidance Document (DRGD), 3rd Edition, 12th Revision July 2026

Local Title
Drug Registration Guidance Document (DRGD), 3rd Edition, 12th Revision July 2026
Country/Region
Malaysia
Competent Authority
National Pharmaceutical Regulatory Agency
Type
Guideline
Status
In force
Release Date
2026-07-16
Implementation Date
2026-07-31

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. 

Contents

Guideline History

Preamble

Table of Contents

    Section A: General Overview

    Section B: Product Registration Process

    Section C: Quality Control

    Section D: Inspection, Licensing, Certificate

    Section E: Post-registration Process

Appendices

Abbreviations and Acronyms

Glossary

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