Taiwan · Taiwan Food and Drug Administration · Biosimilars
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
NT$1,500,000
Fee standard in force since 2021-01-01
Registration of a biological product that is highly similar to a reference biologic approved in Taiwan, with no clinically meaningful differences. The application rests on a stepwise comparability exercise. Copies of approved recombinant biological medicines.
The biosimilar registration fee (recombinant product fee) is NT$1,500,000 for Fee standard in force since 2021-01-01.
1. Submit the application; 2. Comparability review; 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: Regulations for Registration of Medicinal Products Article 41 and Annex 6; biosimilar registration guideline (2024)
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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Biosimilar registration fee (recombinant product fee)Application · Fee standard in force since 2021-01-01 | NT$1,500,000 |
Other routes in Taiwan: New indication or new dosage change, Biological product registration (recombinant products, vaccines, plasma products, allergens), 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 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.