Taiwan · Taiwan Food and Drug Administration · New drugs
Review target
300 days
performance goal
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
NT$500,000
Fee standard in force since 2021-01-01
Application for a product that uses known ingredients in a new therapeutic combination, a new route, a new dosage form, a new dose or a new strength. These products follow the new drug rules. Line extensions and new combinations of ingredients already approved in Taiwan.
The official review target is 300 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The new therapeutic combination or new route review fee is NT$500,000 for Fee standard in force since 2021-01-01.
1. Submit the application; 2. Review, meetings and advisory committee; 3. Applicant supplies missing data (clock stopped); 4. Decision; 5. Collect the drug license.
Outcome: Drug license valid for 5 years and renewable. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act Article 7; Regulations for Registration of Medicinal Products Articles 38 and 39
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 91 days end to end with the official step targets, of which up to 61 days are clock stops (time the applicant uses to answer). 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
| Typical total timeperformance goal. Applications without clinical efficacy and safety data. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 200 days |
| Review targetperformance goal. Applications with clinical efficacy and safety data. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 300 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New therapeutic combination or new route review feeApplication · Fee standard in force since 2021-01-01 | NT$500,000 |
| New dosage form, new dose, new strength or controlled release review feeApplication · Fee standard in force since 2021-01-01 | NT$250,000 |
Other routes in Taiwan: New drug registration, new active substance, New indication or new dosage change, Generic drug registration, 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 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.