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
-
New drugs for serious diseases that mainly affect children or are rare (prevalence of 5 in 10,000 or less) can be designated. They get the 240 day priority review, relaxed document rules and, for some pediatric products, a priority review voucher. New drugs for serious pediatric or rare diseases with unmet medical needs.
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.
1. Designation request; 2. Designation decision (30 days); 3. Registration application with the designation letter; 4. Shortened registration review (240 days); 5. Decision.
Outcome: Designation letter used with the registration application.
Legal basis: TFDA points for designation of drugs for pediatric or rare severe diseases (2019-11-18); Regulations for Registration of Medicinal Products Article 38-5
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 |
|---|---|
| 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, New drug streamlined review (reliance on US, EU and Japan approvals), Breakthrough therapy designation, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.