Taiwan · Taiwan Food and Drug Administration · New drugs
Review target
180 days
official guidance
Legal time limit
-
Not published
Steps
5
5 requirements
Application fee
-
New active substances already approved in the United States, the European Union or Japan can get a shorter review. Type 1 (two of the three approvals) has a 180 day review. Type 2 (all three approvals with the same CMC data) has a 120 day review. New active substances approved by at least two of the US FDA, the EMA and Japan, with no ethnic differences.
The official review target is 180 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Designation request; 2. Designation decision (30 days); 3. Registration application with the designation letter; 4. Shortened registration review (180 days); 5. Decision.
Yes. It relies on approvals from European Union, Japan, United States (shorter review, shorter review, shorter review).
Outcome: Drug license on a shortened review.
Legal basis: TFDA new drug registration streamlined review mechanism (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 210 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
| First review cycleofficial guidance. Type 2 review period. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 120 days |
| Review targetofficial guidance. Type 1. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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, Breakthrough therapy designation, 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 Regulatory section.
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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.