Singapore · Health Sciences Authority · Cell and gene therapy
Review target
270 working days
performance goal
Legal time limit
-
Not published
Steps
6
7 requirements
Application fee
SGD 82,900
Fee list updated 4 September 2026
Higher-risk cell, tissue and gene therapy products (Class 2) need registration. This route is for a product not yet approved by any of the agency's comparable overseas regulators. The applicant gives notice two months before filing. Targets are 50 working days for screening and 270 working days for evaluation, without the applicant's answer time. A Class 2 product, such as a gene-modified or culture-expanded cell therapy, with no approval from the TGA, Health Canada, FDA, EMA or UK MHRA.
The official review target is 270 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The evaluation fee, class 2 ctgtp, full route (per nda package) is SGD 82,900 for Fee list updated 4 September 2026.
1. Pre-submission notice; 2. Online application; 3. Screening (50 days); 4. Evaluation (270 days); 5. Questions (clock stopped); 6. Regulatory decision.
Outcome: Registration of the Class 2 product.
Legal basis: Health Products Act 2007; Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
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 320 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
| Validationperformance goal. Official target, not actual time. | 50 working days |
| Review targetperformance goal. Official target from acceptance, without the applicant's answer time. | 270 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class 2 CTGTP, full route (per NDA package)Application · Fee list updated 4 September 2026 | SGD 82,900 |
| Screening fee, Class 2 CTGTP, full route (per NDA package)Application · Fee list updated 4 September 2026 | SGD 3,050 |
| Pre-market consultation for CTGTP registration (up to one hour)Scientific advice · Fee list updated 4 September 2026 | SGD 210 |
Other routes in Singapore: Class 2 cell, tissue or gene therapy product, abridged evaluation, Class 1 cell or tissue product notification. See all routes on the Singapore 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.