Singapore · Health Sciences Authority · Over-the-counter
Review target
180 working days
performance goal
Legal time limit
-
Not published
Steps
6
12 requirements
Application fee
SGD 11,600
Fee list updated 4 September 2026
Singapore has three access classes: prescription-only, pharmacy-only and general sale list. A non-prescription product is filed as an abridged new drug application. If the active substance is not prescription-only in Singapore and the product is sold without prescription in Australia, Canada, the United States or the United Kingdom, the applicant can ask to skip clinical and nonclinical data and rely on standard reference texts. The agency decides the final access class. A pharmacy-only or general sale medicine already approved as non-prescription by a listed agency.
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, nda-1 or nda-2, abridged route is SGD 11,600 for Fee list updated 4 September 2026.
1. Online application and dossier; 2. Screening (50 days); 3. Screening questions (clock stopped); 4. Evaluation (180 days); 5. Evaluation questions (clock stopped); 6. Regulatory decision.
Yes. It relies on approvals from Australia, Canada, United Kingdom, United States (reference approval required, reference approval required, reference approval required, reference approval required).
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 230 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.
From the official approvals data of this market, all products of this pathway type and segment
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 |
| First review cycleperformance goal. Working days from acceptance to the first set of evaluation questions. | 120 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. | 180 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, NDA-1 or NDA-2, abridged routeApplication · Fee list updated 4 September 2026 | SGD 11,600 |
| Screening fee, abridged new drug applicationApplication · Fee list updated 4 September 2026 | SGD 610 |
Other routes in Singapore: Reclassification of a registered medicine (switch). 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 (31 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.