1. Drug Registration Guidance Document (DRGD), Third Edition, Fourth Revision Jan 2023
2. ASEAN Common Technical Dossier (ACTD)
Glossary used for the ACTD and ACTR
Part III: Nonclinical Document
ACTD Clinical Check List for Product Classification
3. ASEAN Common Technical Requirements (ACTR)
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
