Australia · Therapeutic Goods Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
A framework led by the US Food and Drug Administration for collaborative review of promising cancer medicines. The agency takes part and makes its own decision. Applications can go through the standard, provisional or priority review pathway. High-impact oncology new active substances or new indications selected by the US regulator together with the US applicant.
1. Selection by the US regulator; 2. Australian submission; 3. Collaborative review and decision.
Yes. It relies on approvals from United States (work sharing).
Outcome: An independent Australian registration decision.
Legal basis: Administrative collaboration; the registration itself follows the Therapeutic Goods Act 1989.
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 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, Comparable overseas regulator report-based process, approach B, Priority review pathway for prescription medicines, Provisional approval pathway for prescription medicines, Orphan drug designation, Access Consortium work-sharing, 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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.