Singapore · Health Sciences Authority · Generics
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
-
A pilot in which the agency and Malaysia's National Pharmaceutical Regulatory Agency jointly assess a generic medicine filed in both countries. The pilot is looking for an immediate-release oral solid generic supported by bioequivalence data. A company filing the same immediate-release oral generic in Singapore and Malaysia.
1. Expression of interest to both agencies; 2. Joint assessment; 3. National decisions.
Yes. It relies on approvals from Malaysia (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: Generic drug application, abridged evaluation, Generic drug application, verification evaluation, Generic drug application, verification-CECA evaluation, Standard essential medicine application, 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.