Philippines FDA Publishes Circular on Abridged and Verification Review Pathways

The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-004, which provides insight on the facilitated registration pathways (FRPs) available for new drugs (including vaccines and biologicals), in June 2022. 

The circular covers abridged review and verification review, as well as applications for post-approval changes. The timeline is not more than 45 working days for abridged review and not more than 30 working days for verification review and post-approval changes. 

Approval from reference drug regulatory agencies (RDRAs) is necessary for a product to qualify and be evaluated via these routes. 

More details can be found in “FDA Circular No.2022-004: Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications, June 2022”:  


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