1. Drug Registration Guidance Document (DRGD), 3rd Edition, Second Revision January 2022
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. Guide on Uploading the Documents in QUEST 3+ System
