Taiwan · Taiwan Food and Drug Administration · Biologics
Review target
360 days
performance goal
Legal time limit
-
Not published
Steps
5
11 requirements
Application fee
NT$1,500,000
Fee standard in force since 2021-01-01
Registration route for biological products, including recombinant proteins, vaccines, human plasma products and allergens. The TFDA reviews detailed manufacturing and control data. Vaccines and other listed biologics also need batch lot release before sale. New biological medicines and vaccines.
The official review target is 360 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The blood product, antitoxin or vaccine registration fee is NT$1,500,000 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 Articles 39 and 74; Regulations for Registration of Medicinal Products Articles 4, 22-1 and 41
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
| Review targetperformance goal. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 360 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Blood product, antitoxin or vaccine registration feeApplication · Fee standard in force since 2021-01-01 | NT$1,500,000 |
| Recombinant (genetically engineered) product registration feeApplication · Fee standard in force since 2021-01-01 | NT$1,500,000 |
Other routes in Taiwan: New indication or new dosage change, 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 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.