Having regard to Official dispatch No. 21508/QLD-ĐK and Official dispatch No. 72/QLD-ĐK, Ministry of Health – Viet Nam accepts drug applications, in the ACTD or ICH-CTD format, not only for new medicinal products but also for generics. Viet Nam also sets out specific requirements for product dossiers, on which we shall provide information in the other relevant posts. The layout of ACTD/ACTR could be found here.
Part I Administrative data & Prescribing information
Part II Quality
Part III Safety
Part IV Efficacy
Analytical Validation
ASEAN Guideline on Analytical Validation
Bioavailability & Bioequivalence
ASEAN Guideline for the Conduct of Bioequivalence Studies
Process Validation
ASEAN Guideline on Process Validation
Stability
ASEAN Guidline on Stability Study of Drug Product
Variation
ASEAN Variation Guideline for Pharmaceutical Products
