Australia · Therapeutic Goods Administration · Generics
Review target
-
Not published
Legal time limit
255 working days
regulation
Steps
6
4 requirements
Application fee
A$94,111
FY2026-27
The route for a generic version of a registered prescription medicine. It uses the same milestone process, with shorter planned first round and decision phases. Advisory committee review is optional. A new generic prescription medicine supported by bioequivalence data or a justification.
The new generic product, evaluation fee is A$94,111 for FY2026-27.
1. Pre-submission planning form; 2. Dossier submission and acceptance check; 3. First round assessment (122 days); 4. Applicant answers the combined questions; 5. Second round assessment (61 days); 6. Delegate decision (42 days).
Outcome: Registration in the Australian Register of Therapeutic Goods.
Legal basis: Therapeutic Goods Act 1989, section 23; Therapeutic Goods Regulations 1990, regulation 16C
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 285 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 from acceptance to decision. Applicant answer time is not counted. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New generic product, evaluation feeApplication · FY2026-27 | A$94,111 |
| New generic product, application feeApplication · FY2026-27 | A$23,711 |
Other routes in Australia: Registration of a new prescription medicine (standard pathway), Extension of indications and major variations of a registered prescription 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.