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Taiwan's medicines regulator. Its statutory processing time for a new chemical entity or biological product is 360 calendar days, and it has priority review, accelerated approval and breakthrough routes that it says bring many reviews under 240 days.
The Food and Drug Administration was formed on 1 January 2010 under the former Department of Health and became an administration of the Ministry of Health and Welfare on 23 July 2013. Its offices are in Nangang District, Taipei.
Its table of processing times for applications, as amended on 3 March 2026 (notice FDA藥字第1151400412號), gives 360 calendar days for a new chemical entity, including botanical new drugs, or a biological product: 30 days for classification and assignment, 300 for filing and review meetings, advisory committee discussion and labelling review, and 30 to close. Orphan drugs also have 360 days, and new indications, routes or combinations with clinical data 300. In July 2022 the Ministry reported that the TFDA approved 134 new drugs and new formulations in 2021, and that its accelerated mechanisms (abridged review, priority review, accelerated approval, breakthrough therapy and the scheme for paediatric or rare serious diseases) cut review times from the general 360 days to under 240 for many of them. In 2015 its 15 priority reviews took a median of 171 days.
The Center for Drug Evaluation carries out the technical reviews: in 2025 it completed 141 new drug applications, 38 of them antineoplastic or immunomodulating medicines, and 29 qualified for at least one expedited route.
The coordinates are a Nangang district centroid, not the street address.
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