Australia · Therapeutic Goods Administration · New drugs
Review target
-
Not published
Legal time limit
175 working days
regulation
Steps
4
4 requirements
Application fee
-
A shortened review based mostly on the overseas assessment reports, with room for the agency to evaluate some extra data, such as updated stability data or a new manufacturing site. There is no limit on how old the overseas approval is. The legal limit is 175 working days. The medicine is the same as one approved by a comparable overseas regulator, but some extra data need evaluation, or the overseas approval is older than 12 months.
1. Submission with full overseas reports; 2. Preliminary assessment; 3. Review of reports and extra data (175 days); 4. Decision.
Yes. It relies on approvals from Canada, Switzerland, European Union, United Kingdom, Japan, Singapore, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: Registration in the Australian Register of Therapeutic Goods.
Legal basis: Therapeutic Goods Regulations 1990, regulations 16C(3)(b) and 16DA(1)
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 175 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
| Legal time limitregulation. Legal limit when the conditions in regulation 16DA(1) are met. Targets are not actual review times. | 175 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Australia: Registration of a new prescription medicine (standard pathway), Extension of indications and major variations of a registered prescription medicine, Registration of a new generic prescription medicine, Registration of a biosimilar medicine, Comparable overseas regulator report-based process, approach A, Priority review pathway for prescription medicines, Provisional approval pathway for prescription medicines, Orphan drug designation, Access Consortium work-sharing, Project Orbis collaborative oncology review, How combination products are regulated. See all routes on the Australia 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.