Australia · Therapeutic Goods Administration · New drugs
Review target
150 working days
official guidance
Legal time limit
255 working days
regulation
Steps
4
5 requirements
Application fee
A$260,579
FY2026-27
A faster review for vital and life-saving prescription medicines with a complete dossier. The sponsor first obtains a priority determination. The registration review then has a target of 150 working days, with questions sent as they arise. The approval is the same as a standard approval. A new prescription medicine or new indication for a life-threatening or seriously debilitating condition, with substantial evidence of a major therapeutic advance.
The official review target is 150 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 new prescription medicine in the priority pathway, evaluation fee is A$260,579 for FY2026-27.
1. Priority determination (20 days); 2. Lodge the registration application; 3. First round assessment with rolling questions (91 days); 4. Decision (30 days).
Outcome: Full registration, identical to registration through the standard pathway.
Legal basis: Therapeutic Goods Regulations 1990, Part 3C (regulations 16P to 16T)
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 324 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. It is a target, not an actual review time. | 150 working days |
| Legal time limitregulation. The general legal limit for registration applications still applies. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New prescription medicine in the priority pathway, evaluation feeApplication · FY2026-27 · Waived for a matching orphan designation. | A$260,579 |
| New indications medicine in the priority pathway, evaluation feeSupplement · FY2026-27 | A$154,978 |
| New prescription medicine in the priority pathway, application feeApplication · FY2026-27 · Waived for a matching orphan designation. | A$65,145 |
| New indications medicine in the priority pathway, application feeSupplement · FY2026-27 | A$38,744 |
| Priority determination of a prescription medicineDesignation · FY2026-27 · Refunded when an orphan designation is made after the fee is paid, under the rules. | A$16,012 |
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, 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.