Application Process and Requirements for Post-approval Changes of Pharmaceutical Products

I. BACKGROUND/RATIONALE

Prior to the full adoption and implementation of the Association of Southeast Asian Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR), Marketing Authorization Holders (MAHs) referred to the provisions of PSD Memo 02-05, "Updated Checklist of Requirements for Request of Amendment and Revalidation", FDA Circular No. 2011-002, "Application for Revisions/Updates in the Package Insert, Patient Leaflet Information, Prescribing Information, Core Data Sheet, and Basic Succinct Statement", and other national regulations to support post-approval changes to their registered products. However, the said regulations proved to be insufficient to cover many other possible post-approval change scenarios. Therefore, a more comprehensive guideline is needed to address in detail the requirements and applications process for post-approval changes.

 

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