CDRR Downloadables

CDRR Checklist

 

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)

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

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