Guidance for Generic Medicine

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1. Drug Registration Guidance Document (DRGD), Third Edition, Fourth Revision Jan 2023

 

2. ASEAN Common Technical Dossier (ACTD)

Organization of the Dossier

Glossary used for the ACTD and ACTR

Part II: Quality

Part III: Nonclinical Document

Part IV: Clinical Document

ACTD Clinical Check List for Product Classification

 

3. ASEAN Common Technical Requirements (ACTR)

ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (includes all annexes)

ASEAN Guideline on Stability Study of Drug Product (R1)

ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies

 

4. Malaysian Guideline

Malaysian Variation Guideline for Pharmaceutical Products, 2nd Edition (July 2022) 

 

5. Guide on Uploading the Documents in QUEST 3+ System

Section E12 & E13

Section P9