Downloadables

Checklist of Requirements


Drug Registration

Post-Approval Changes (PACs)

 

Guidance Documents


ASEAN Common Technical Dossier (ACTD)

Part I

Part II

Part III

Part IV

 ASEAN Common Technical Requirements(ACTR)

 Analytical Validation

Bioavailability & Bioequivalence Study

Process Validation

Stability

Variation

 

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