Snapshot

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

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

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Priority Review: 240 days; Priority + Abbreviated: 150 days (1) Applicants should apply in advance to request to use this pathway. They should attach all the required documents to allow FDA to review their eligibility. The application form should be submitted at the same time as payment of fees. (2) The Food and Drug Administration will conduct an evaluation based on the information submitted by the manufacturer and notify the applicant within 30 days whether their product meets accelerated approval criteria or not. If a positive response is received, the applicant should attach the decision letter to their marketing authorisation application. The accelerated approval mechanism may be adopted only after receiving the notification letter..