Australia · Therapeutic Goods Administration · New drugs
Review target
220 working days
official guidance
Legal time limit
255 working days
regulation
Steps
8
9 requirements
Application fee
A$246,401
FY2026-27
The standard route for a new prescription medicine, including biological medicines and vaccines. The agency runs the review in eight phases with fixed milestones. The rules set a limit of 255 working days from acceptance to decision. New chemical entities and other new prescription medicines that need clinical, nonclinical and quality data.
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 new chemical entity, evaluation fee is A$246,401 for FY2026-27.
1. Pre-submission planning form; 2. Dossier submission and acceptance check (21 days); 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 (42 days); 8. Post-decision and register entry.
Outcome: Registration in the Australian Register of Therapeutic Goods.
Legal basis: Therapeutic Goods Act 1989, section 23 and section 25; 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 305 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
| Validationregulation. Legal limit for telling the applicant whether the application passed preliminary assessment. | 40 working days |
| Review targetofficial guidance. Internal target from acceptance to decision under the milestone process. | 220 working days |
| Legal time limitregulation. Legal limit from acceptance to decision. Time the applicant takes to answer questions is not counted. Targets are not actual review times. | 255 working days |
| Typical total timeofficial guidance. Planned average of about 11 months, including time for applicant activities. This is a design target, not a measured time. | 330 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New chemical entity, evaluation feeApplication · FY2026-27 · Waived when a matching orphan drug designation is in force. | A$246,401 |
| New chemical entity, application feeApplication · FY2026-27 · Waived when a matching orphan drug designation is in force. | A$61,479 |
| New strain of a COVID-19, RSV or influenza vaccine closely related to an existing registered vaccine, evaluation feeApplication · FY2026-27 | A$5,610 |
| New strain of a COVID-19, RSV or influenza vaccine closely related to an existing registered vaccine, application feeApplication · FY2026-27 | A$1,405 |
Other routes in Australia: 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, 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 (31 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.