Taiwan · Taiwan Food and Drug Administration · Cell and gene therapy
Review target
120 days
official guidance
Legal time limit
-
Not published
Steps
6
5 requirements
Application fee
NT$1,500,000
Fee standard in force since 2026-01-01
A time-limited permit for cell, gene or tissue products that treat life-threatening or severely disabling diseases, granted after Phase II when safety and preliminary efficacy are shown. It lasts up to 5 years, cannot be renewed and requires an efficacy confirmation trial. Regenerative products for serious diseases where confirmatory data are not yet complete.
The official review target is 120 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The conditional permit application fee is NT$1,500,000 for Fee standard in force since 2026-01-01.
1. Optional recognition of a life-threatening or severely disabling disease; 2. Submit the conditional permit application online; 3. Technical review (120 days); 4. Regenerative medicine review committee; 5. Conditional permit granted; 6. Confirmatory efficacy trial and conversion.
Outcome: Conditional permit valid up to 5 years; conversion to a full license after the conditions are met. Valid for 5 years.
Legal basis: Regenerative Medicinal Products Act Articles 6, 9 and 10
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 120 days end to end with the official step targets. 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 targetofficial guidance. Technical data review period stated in the application notes. Committee review follows. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 120 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Conditional permit application feeApplication · Fee standard in force since 2026-01-01 | NT$1,500,000 |
| Recognition of a life-threatening or severely disabling diseaseDesignation · Fee standard in force since 2026-01-01 | NT$30,000 |
Other routes in Taiwan: Regenerative medicinal product license (cell, gene, tissue engineered and composite products), Class 3 device license. 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.