Singapore · Health Sciences Authority · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
1 requirements
Application fee
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Singapore is a member of the Access Consortium with Australia, Canada, Switzerland and the United Kingdom. Work-sharing initiatives cover new active substances, generics and biosimilars filed with at least two member agencies. The agencies share the assessment work, and each agency issues its own decision. A company filing the same medicine in Singapore and at least one other member country.
1. Expression of interest; 2. Parallel filings; 3. Coordinated assessment; 4. National decisions.
Yes. It relies on approvals from Australia, Canada, Switzerland, United Kingdom (work sharing, work sharing, work sharing, work sharing).
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).
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), Generic drug application, abridged evaluation, Generic drug application, verification evaluation, Generic drug application, verification-CECA evaluation, Standard essential medicine application, Biosimilar application, Priority review, Project Orbis (cancer medicines), Singapore-Malaysia generic work-sharing pilot, Special access for an unregistered medicine (named patient). See all routes on the or explore them in the .
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.