CDRR Downloadables

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)

Quality Data for Pharmaceutical Registration

Nonclinical Data (Safety) and Clinical Data (Efficacy) for Pharmaceutical Registration

 Analytical Validation

Bioavailability & Bioequivalence Study

Provisitional List

Process Validation

Stability

Variation