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Drug Registration Guidance Document (DRGD)
Local Title:
Drug Registration Guidance Document (DRGD)
Country/Region:
Malaysia
Competent Authority:
National Pharmaceutical Regulatory Agency
Type:
Guideline
Status:
In force
Release Date:
2025-07-01
Implementation Date:
2025-07-01
Applicable Scope:
Health supplement
Document
Language Source Title Access
EN
Official Drug Registration Guidance Document (DRGD)
Summary

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

User Guide