Taiwan · Taiwan Food and Drug Administration · New drugs
Review target
240 days
official guidance
Legal time limit
-
Not published
Steps
5
4 requirements
Application fee
NT$30,000
Fee standard in force since 2021-01-01
Drugs for serious or rare diseases with early clinical evidence of substantial improvement, and a meaningful trial in Taiwan, can get two-way consultation, module-based rolling review of the CTD dossier, and the 240 day priority review. Promising drugs in development that are tested in Taiwan.
The official review target is 240 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The breakthrough therapy designation request fee is NT$30,000 for Fee standard in force since 2021-01-01.
1. Breakthrough designation request; 2. Designation decision (30 days); 3. Two-way consultation and progress reports; 4. Module-based rolling review; 5. Registration with priority review (240 days).
Outcome: Designation with consultation, rolling review and priority review.
Legal basis: TFDA points for breakthrough therapy designation (amended 2019-11-18)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 270 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 240 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Breakthrough therapy designation request feeDesignation · Fee standard in force since 2021-01-01 | NT$30,000 |
Other routes in Taiwan: New drug registration, new active substance, New drug registration, known ingredient (new combination, route, dosage form, dose or strength), New indication or new dosage change, Generic drug registration, Biological product registration (recombinant products, vaccines, plasma products, allergens), Biosimilar registration, Batch lot release for vaccines and other listed biologics, New drug priority review, New drug accelerated approval, New drug streamlined review (reliance on US, EU and Japan approvals), Designation for drugs for pediatric or rare severe diseases, Special approval to make or import unlicensed drugs. See all routes on the Taiwan page or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.