Singapore · Health Sciences Authority · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
-
An applicant on the abridged route can ask for priority review of a life-saving drug for a serious, life-threatening condition with unmet need in Singapore. Cancer and infectious diseases such as dengue, tuberculosis, hepatitis and malaria get primary consideration. The agency says at acceptance whether priority review is granted. It has not published a separate target time. A new medicine on the abridged route that fills a local unmet need for a serious condition.
1. Request with the abridged application; 2. Screening; 3. Decision on priority review; 4. Priority evaluation.
Outcome: Faster evaluation of the abridged application if granted.
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Singapore: New drug application, full evaluation, New drug application, abridged evaluation, New drug application, verification evaluation, New drug application for a registered active ingredient (NDA-2), Standard essential medicine application, 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.