Taiwan · Taiwan Food and Drug Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
The TFDA can allow the manufacture or import of a specific unlicensed drug for life-threatening or severely disabling diseases when there is no suitable alternative in Taiwan, or for public health emergencies. Patient need or emergencies where no licensed product is available.
1. Request for special approval; 2. Review; 3. Special approval to make or import.
Outcome: Special approval for a defined manufacture or import.
Legal basis: Pharmaceutical Affairs Act Article 48-2
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
| No time targets published. |
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, Designation for drugs for pediatric or rare severe diseases. 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.