Singapore · Health Sciences Authority · Generics
Review target
120 working days
performance goal
Legal time limit
-
Not published
Steps
6
12 requirements
Application fee
SGD 10,600
Fee list updated 4 September 2026
A reliance route for a chemical generic approved by at least one of the agency's six reference regulators within the last two years. Quality must be identical to that approval, and the applicant sends the reference agency's unredacted assessment reports. The target is 50 working days for screening and 120 working days for evaluation. A chemical generic with a recent approval from the FDA, the EMA (centralised), Health Canada, the UK MHRA, Swissmedic or the TGA.
The official review target is 120 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, gda-1, verification route is SGD 10,600 for Fee list updated 4 September 2026.
1. Online application and dossier; 2. Screening (50 days); 3. Screening questions (clock stopped); 4. Evaluation (120 days); 5. Evaluation questions (clock stopped); 6. Regulatory decision.
Yes. It relies on approvals from Australia, Canada, Switzerland, European Union, United Kingdom, United States (verification, verification, verification, verification, verification, verification).
Outcome: Registration in the Register of Therapeutic Products. The registration is kept by paying a yearly retention fee.
Legal basis: Health Products Act 2007; Health Products (Therapeutic Products) Regulations 2016
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 170 days end to end with the official step targets, of which up to 20 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
| Longest clock stopofficial guidance. Time allowed to answer each screening question. | 20 working days |
| Validationperformance goal. Screening target. Time spent waiting for the applicant's answers is not counted. | 50 working days |
| Review targetperformance goal. Evaluation target from acceptance to decision, without the applicant's answer time. These are official targets, not actual review times. | 120 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, GDA-1, verification routeApplication · Fee list updated 4 September 2026 | SGD 10,600 |
| Evaluation fee, GDA-2, verification routeApplication · Fee list updated 4 September 2026 | SGD 5,500 |
| Screening fee, generic drug application, verification routeApplication · Fee list updated 4 September 2026 | SGD 610 |
Other routes in Singapore: Generic drug application, abridged evaluation, Generic drug application, verification-CECA evaluation, Standard essential medicine application, Access Consortium work sharing, Singapore-Malaysia generic work-sharing pilot. 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 (35 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.