Snapshot

The Abbreviated Review pathway has been developed by the Taiwan Food and Drug Administration of Taiwan (Chinese Taipei).

This pathway can be used where new chemical entities.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA Japan United States

Target time assessment is Abbreviated Review: 180 days. Submission → filing meeting (~60 days) → review meeting (~100 days) → notification for completion of review (~130 days) → approval/non-approval by TFDA (~180 days).