Philippines: FDA Circular No.2022-004 || Implementing Guidelines for Drug Products

Food and Drug Administration (FDA) Circular No. 2022-004, published by the FDA in June 2022, offers information on the facilitated registration pathways (FRPs) accessible for new pharmaceuticals (including vaccines and biologicals).

The circular addresses applications for post-approval amendments as well as abbreviated review and verification review. Abridged reviews cannot take longer than 45 working days, while verification reviews and post-approval revisions cannot take longer than 30 working days.

A product cannot be qualified and evaluated unless it has received approval from reference drug regulatory agencies (RDRAs).

Source:

https://www.fda.gov.ph/fda-circular-no-2022-004-implementing-guidelines-on-the-abridged-and-verification-review-pathways-for-new-drug-registration-applications-in-accordance-with-administrative-order-no-2020-0045/

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