Singapore · Health Sciences Authority · New drugs
Review target
14 working days
performance goal
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Licensed hospitals, clinics and nursing homes can ask the agency to approve import of an unregistered medicine for a specific patient. It is meant for life-saving therapy when no effective registered option exists. Each consignment needs approval, holds up to three months of supply per patient, and is valid for 6 months. The target is 14 working days and there is no fee. The agency does not assess the product. A doctor needs an unregistered medicine for a patient whose condition would suffer without it.
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.
1. Signed request from the doctor; 2. Online application by the importer; 3. Agency review (14 days); 4. Consignment approval.
Outcome: A consignment approval for named-patient use. The product is not registered.
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 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, excluding stop-clock time. | 14 working days |
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, Priority review, Project Orbis (cancer medicines), Access Consortium work sharing. 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.