Singapore · Health Sciences Authority · Cell and gene therapy
Review target
180 working days
performance goal
Legal time limit
-
Not published
Steps
5
7 requirements
Application fee
SGD 13,900
Fee list updated 4 September 2026
For a Class 2 cell, tissue or gene therapy product already approved by at least one comparable overseas regulator: the TGA, Health Canada, the FDA, the EMA or the UK MHRA. Targets are 50 working days for screening and 180 working days for evaluation, without the applicant's answer time. A Class 2 product with at least one approval from a comparable overseas regulator.
The official review target is 180 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 nda-1 or nda-2, abridged route is SGD 13,900 for Fee list updated 4 September 2026.
1. Online application; 2. Screening (50 days); 3. Evaluation (180 days); 4. Questions (clock stopped); 5. Regulatory decision.
Yes. It relies on approvals from Australia, Canada, European Union, United Kingdom, United States (reference approval required, reference approval required, reference approval required, reference approval required, reference approval required).
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 230 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. | 180 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class 2 CTGTP NDA-1 or NDA-2, abridged routeApplication · Fee list updated 4 September 2026 | SGD 13,900 |
| Evaluation fee, Class 2 CTGTP NDA-3, abridged routeApplication · Fee list updated 4 September 2026 | SGD 5,900 |
| Screening fee, Class 2 CTGTP, abridged route (per NDA)Application · Fee list updated 4 September 2026 | SGD 600 |
Other routes in Singapore: Class 2 cell, tissue or gene therapy product, full 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.