Australia · Therapeutic Goods Administration · New drugs
Review target
-
Not published
Legal time limit
255 working days
regulation
Steps
7
3 requirements
Application fee
A$146,178
FY2026-27
The route to add a new use, or to make a major change such as a new strength, dosage form or formulation, for a medicine already on the register when clinical, nonclinical or bioequivalence data are needed. It follows the same eight-phase process as a new medicine. A new indication or a major change to a registered prescription medicine that needs evaluation of data.
The extension of indications, evaluation fee is A$146,178 for FY2026-27.
1. Pre-submission planning form; 2. Dossier submission and acceptance check; 3. First round assessment (152 days); 4. Applicant answers the combined questions; 5. Second round assessment (30 days); 6. Expert advisory committee review; 7. Delegate decision.
Outcome: A new or varied register entry.
Legal basis: Therapeutic Goods Act 1989, section 23 and section 9D; Therapeutic Goods Regulations 1990, regulations 16C and 16D
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 242 days end to end with the official step targets, of which up to 60 days are clock stops (time the applicant uses to answer). 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 for registration applications under section 23. Applicant answer time is not counted. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Extension of indications, evaluation feeSupplement · FY2026-27 | A$146,178 |
| Major variation, evaluation feeSupplement · FY2026-27 | A$95,333 |
| Extension of indications, application feeSupplement · FY2026-27 | A$36,667 |
| Major variation, application feeSupplement · FY2026-27 | A$23,956 |
Other routes in Australia: Registration of a new prescription medicine (standard pathway), 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, 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.