Australia · Therapeutic Goods Administration · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
4
3 requirements
Application fee
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A designation for prescription medicines for rare conditions. It waives the application and evaluation fees for registration while it is in force. The designation lasts 6 months and can be extended once by 6 months. The registration itself can use any eligible pathway. One indication for a life-threatening or seriously debilitating condition that affects fewer than 5 in 10,000 people in Australia.
1. Designation application; 2. Assessment and decision; 3. Designation in force (183 days); 4. Registration application.
Outcome: Orphan designation and a fee waiver for a matching registration application.
Legal basis: Therapeutic Goods Regulations 1990, Part 3B (regulations 16H to 16M) and regulation 45(12)
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 183 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
| 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, 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.