Singapore · Health Sciences Authority · New drugs
Review target
270 working days
performance goal
Legal time limit
-
Not published
Steps
7
12 requirements
Application fee
SGD 83,100
Fee list updated 4 September 2026
For a new medicine that no drug regulatory agency in the world has approved yet. The agency reviews the full quality, nonclinical and clinical data. The applicant gives notice at least two months before filing. The target is 50 working days for screening and 270 working days for evaluation, without the applicant's answer time. Products with new safety and efficacy data get 5 years of data exclusivity. A new chemical or biological medicine, including a vaccine, that has no approval from any drug regulatory agency at the time of filing.
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, new drug application, full route (per submission package) is SGD 83,100 for Fee list updated 4 September 2026.
1. Pre-submission notice; 2. Online application and dossier; 3. Screening (50 days); 4. Screening questions (clock stopped); 5. Evaluation (270 days); 6. Evaluation questions (clock stopped); 7. Regulatory decision.
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 320 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 |
| First review cycleperformance goal. Working days from acceptance to the first set of evaluation questions. | 160 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. | 270 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, new drug application, full route (per submission package)Application · Fee list updated 4 September 2026 | SGD 83,100 |
| Screening fee, new drug application, full route (per submission package)Application · Fee list updated 4 September 2026 | SGD 3,060 |
Other routes in Singapore: New drug application, abridged evaluation, New drug application, verification evaluation, New drug application for a registered active ingredient (NDA-2), Standard essential medicine application, Priority review, Project Orbis (cancer medicines), Access Consortium work sharing, Special access for an unregistered medicine (named patient). 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 (30 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.