Singapore · Health Sciences Authority · Cell and gene therapy
Review target
14 working days
performance goal
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
SGD 95
Fee list updated 4 September 2026
Lower-risk (Class 1) cell and tissue products do not need registration. The supplier files a product notification and must receive the agency's written acceptance before supply. The outcome is expected within 14 working days and the fee is 95 Singapore dollars. A minimally manipulated tissue product for homologous use, such as a bone graft for orthopedic use.
The official review target is 14 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The class 1 ctgtp product notification is SGD 95 for Fee list updated 4 September 2026.
1. Product notification; 2. Agency check (14 days); 3. Written acceptance.
Outcome: Listing as a notified Class 1 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 14 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 targetperformance goal. Official target, not actual time. | 14 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Class 1 CTGTP product notificationApplication · Fee list updated 4 September 2026 | SGD 95 |
Other routes in Singapore: Class 2 cell, tissue or gene therapy product, full evaluation, Class 2 cell, tissue or gene therapy product, abridged evaluation. 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.