Snapshot

The Breakthrough Therapy Designation pathway has been developed by the of Taiwan (Chinese Taipei).

This pathway can be used where new drugs with new ingredients that are for serious diseases or rare diseases..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

(1) Manufacturers should complete the application form and attach early clinical evidence materials. (2) The time when the manufacturer submits the application shall not be later than the second phase clinical trial completion report forward. (3) The FDA will evaluate the case based on the information submitted by the manufacturer and notify the applicant of its decision on whether the pathway can be used within 30 days. As a result of the manufacturer's certification, if any item of the submitted information is incomplete, the certification will not be granted. (4) The manufacturer should report the implementation progress of the case to the FDA at least every 3 months after passing the certification and also submit its product development plans. For drugs that have been identified as applicable to this key point, if the manufacturer needs assistance during the research and development of the case, to resolve issues related to regulations, the FDA may be consulted, and the FDA may invite external experts and the Pharmaceutical Inspection Center to hold a meeting to discuss the applicant's questions. (5) Module-Based Rolling Review: Once the product is deemed to have passed, the manufacturer may, before applying for drug inspection and registration, apply for the product in accordance with the general technical document format (Common Technical Document; CTD), and apply to the Center for Pharmaceutical Inspection. In addition, the stability test data should be completed before obtaining the certificate. (6) When applying for drug inspection and registration for drugs that have been identified as applicable to this key point, the declared indications, those that are consistent with the designation, can apply for the new drug priority review mechanism and do not need to apply for priority review separately.