Snapshot

The Facilitated Review Pathway (Abridged Review) pathway has been developed by the Philippine Food and Drug Administration (FDA) of Philippines.

This pathway can be used where New drugs, vaccines, and biologicals. All generic products with FDA-approved equivalents shall not be considered new drugs. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Belgium Canada EU-EMA France Germany Italy Japan Netherlands Singapore Switzerland United Kingdom United States

The turnaround time shall start after receipt of the proof of payment with the complete application dossier. Abridged review will take not more than 45 working days.