FAQ
Drugs

Is there any facilitated regulatory pathway of drug registration in Taiwan?

刊登日期:2021-10-14  |  點閱次數 : 2564 次 

Taiwan Food and Drug Administration (TFDA) has developed five expedited programs to help to accelerate the application process. Expedited programs include “Abbreviated Review”, “Priority Review”, “Accelerated Approval”, “Breakthrough Therapy” and “Pediatric and Rare Severe Disease Priority Review Voucher Program”.

 

An applicant should apply for designation in advance. At the time of NDA submission, the applicant should provide the designation letter.

 

To find further details, please refer to the CDE website: Drugs>New Drug Application (NDA)

 

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