Snapshot

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

This pathway can be used where new medical products (new chemical entities, new combination, new indication, and new administration route).

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Priority Review: 240 days. Submission → filing meeting (~40 days) → review meeting (~100 days) → notification for completion of review (~130 days) → advisory committee (130~210 days) → approval/non-approval by TFDA (~240 days). .