Australia · Therapeutic Goods Administration · New drugs
Review target
220 working days
official guidance
Legal time limit
255 working days
regulation
Steps
5
5 requirements
Application fee
A$321,446
FY2026-27
Time-limited registration based on preliminary clinical data for a promising medicine, while the sponsor completes confirmatory studies. The sponsor first obtains a provisional determination. Provisional registration lasts 2 years and can be extended twice, by up to 2 years each time. A new medicine or new indication for a life-threatening or seriously debilitating condition, where preliminary clinical data suggest a major therapeutic advance.
The official review target is 220 working days (official guidance). The legal time limit is 255 working days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The provisional registration of a new prescription medicine, evaluation fee is A$321,446 for FY2026-27.
1. Provisional determination (20 days); 2. Lodge the provisional registration application; 3. First round assessment (152 days); 4. Decision; 5. Provisional registration period (730 days).
Outcome: Provisional registration with conditions, which can later move to full registration. Valid for 2 years.
Legal basis: Therapeutic Goods Act 1989, sections 22C to 22F and section 29; Therapeutic Goods Regulations 1990, regulations 10K and 10L
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 902 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
| Review targetofficial guidance. Target from acceptance to decision; provisional applications are prioritised within this target. | 220 working days |
| Legal time limitregulation. Same legal limit as standard registration. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Provisional registration of a new prescription medicine, evaluation feeApplication · FY2026-27 | A$321,446 |
| Provisional registration of a new indications medicine, evaluation feeSupplement · FY2026-27 | A$212,057 |
| Transition from provisional to full registration, evaluation feeApplication · FY2026-27 | A$154,611 |
| Provisional registration of a new prescription medicine, application feeApplication · FY2026-27 | A$61,600 |
| Provisional registration of a new indications medicine, application feeSupplement · FY2026-27 | A$36,790 |
| Transition from provisional to full registration, application feeApplication · FY2026-27 | A$36,667 |
| Extension of provisional registrationRenewal · FY2026-27 | A$22,123 |
| Provisional determination of a prescription medicineDesignation · FY2026-27 · Waived for a designated orphan drug. | A$16,012 |
| Extension of provisional determinationDesignation · FY2026-27 | A$5,806 |
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, 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 (25 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.