Taiwan · Taiwan Food and Drug Administration · Cell and gene therapy
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
NT$1,500,000
Fee standard in force since 2026-01-01
Since 1 January 2026, gene therapy, cell therapy, tissue engineered and composite products are regulated as regenerative medicinal products. A full license is valid for 5 years. Composite products combine device-type structural materials with cells or genes. Cell, gene and tissue engineered products, including those combined with device materials, with full evidence of safety and efficacy.
The regenerative medicinal product registration fee (license or conditional permit) is NT$1,500,000 for Fee standard in force since 2026-01-01.
1. Submit the application; 2. 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: Regenerative Medicinal Products Act Articles 3 to 8; Regulations for registration and permits of regenerative medicinal products
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 |
|---|---|
| Regenerative medicinal product registration fee (license or conditional permit)Application · Fee standard in force since 2026-01-01 | NT$1,500,000 |
Other routes in Taiwan: Conditional permit for regenerative medicinal 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.