Taiwan · Taiwan Food and Drug Administration · Vaccines
Review target
70 days
performance goal
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
Serums, antitoxins, vaccines, toxoids and bacterial suspensions cannot be sold until the regulator has sampled and tested each batch and applied a release seal. This step follows product registration. Every batch of an approved vaccine or other listed biologic before it is sold.
The official review target is 70 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Apply for batch release; 2. Sampling and testing (70 days); 3. Release seal applied.
Outcome: Release seal on the batch; the batch can be sold.
Legal basis: Pharmaceutical Affairs Act Article 74
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 70 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Most vaccines. BCG, PPD, toxoid and DTP combination vaccines have a 100 day period. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 70 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Taiwan: New indication or new dosage change, Biological product registration (recombinant products, vaccines, plasma products, allergens), Biosimilar 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.