ACTD/ACTR Pharmaceutical technical documents

341
ACTD/ACTR Pharmaceutical technical documents
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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.

ACTD Organisation Dossier

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

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