Australia · Therapeutic Goods Administration · Cell and gene therapy
Review target
220 working days
official guidance
Legal time limit
255 working days
regulation
Steps
8
4 requirements
Application fee
A$314,145
FY2026-27
Products made from human cells or tissues, or from live animal cells, are regulated as biologicals in four risk classes. Class 2, 3 and 4 products need an evaluated dossier. Genetically modified cells, such as CAR T cells, are Class 4. The legal limit for evaluation is 255 working days. Cell and tissue products that are Class 2 (low risk), Class 3 (medium risk) or Class 4 (high risk) biologicals.
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 class 4 biological, priority evaluation fee is A$314,145 for FY2026-27.
1. Pre-submission meeting; 2. Submission and preliminary assessment (30 days); 3. First round of evaluation (100 days); 4. Applicant answers questions (30 days); 5. Second round of evaluation (20 days); 6. Advisory Committee on Biologicals; 7. Decision (20 days); 8. Register entry (20 days).
Outcome: Inclusion of the biological in the Australian Register of Therapeutic Goods.
Legal basis: Therapeutic Goods Act 1989, Chapter 3 Part 3-2A; Therapeutic Goods Regulations 1990, regulation 16GC and Schedule 16
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 280 days end to end with the official step targets, of which up to 30 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 the preliminary assessment notice. | 30 working days |
| Review targetofficial guidance. Total evaluation target of 200 to 220 working days. It is a target, not an actual time. | 220 working days |
| Legal time limitregulation. Legal limit from the preliminary assessment notice. Applicant answer time is not counted. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Class 4 biological, priority evaluation feeApplication · FY2026-27 | A$314,145 |
| Class 4 biological, evaluation feeApplication · FY2026-27 | A$301,645 |
| Class 3 biological, evaluation feeApplication · FY2026-27 | A$185,655 |
| Class 2 biological, evaluation feeApplication · FY2026-27 | A$92,766 |
| Priority determination for a biologicalDesignation · FY2026-27 | A$16,642 |
| Class 2, 3 or 4 biological, application feeApplication · FY2026-27 | A$1,394 |
Other routes in Australia: 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 (24 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.