Taiwan · Taiwan Food and Drug Administration · New drugs
Review target
180 days
performance goal
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
NT$250,000
Fee standard in force since 2021-01-01
A change application that adds or changes an indication or a dosage on an existing drug license. The holder submits full clinical reports or literature. An approved drug that gains a new indication or a new dosage regimen.
The official review target is 180 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The new indication, new dosage or new category change fee is NT$250,000 for Fee standard in force since 2021-01-01.
1. Submit the change application; 2. Review; 3. Decision and license annotation.
Outcome: The change is noted on the existing license.
Legal basis: Pharmaceutical Affairs Act Articles 40-3 and 46; Regulations for Registration of Medicinal Products Articles 54 and 55
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. 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 |
|---|---|
| New indication, new dosage or new category change feeSupplement · Fee standard in force since 2021-01-01 | NT$250,000 |
Other routes in Taiwan: New drug registration, new active substance, New drug registration, known ingredient (new combination, route, dosage form, dose or strength), 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, 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.