Australia · Therapeutic Goods Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
Australia works with Canada, Singapore, Switzerland and the United Kingdom on coordinated reviews. Each agency makes its own decision. There are work-sharing initiatives for new active substances, generic medicines and biosimilars. New chemical or biological entity applications, or new indication applications, submitted to two or more Access agencies.
1. Expression of interest; 2. Coordinated review; 3. Independent decisions.
Yes. It relies on approvals from Canada, Switzerland, United Kingdom, Singapore (work sharing, work sharing, work sharing, work sharing).
Outcome: An independent Australian registration decision.
Legal basis: Administrative work-sharing arrangement; 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, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.