The Australian regulatory and ethics pathway
Faster than you might think, and Avion CRO manages it end to end.
01
The CTN scheme, in plain English
Most clinical trials in Australia proceed under the Clinical Trial Notification (CTN) scheme. Once ethics approval is in place, the trial is notified to the Therapeutic Goods Administration (TGA) rather than going through a lengthy pre-approval process like a US IND.
02
Ethics review that keeps pace
Studies are reviewed by a Human Research Ethics Committee (HREC), with an efficient, well-understood process from submission to approval. Typical HREC time frames from submission to approval are 4- to 8-week ethics and regulatory timelines via CTN pathway, with rapid Study Start-up timelines of 3-4 months vs 8-9 months in US/EUR.
03
No US IND required
Companies conducting trials in Australia do not require US FDA IND approval, often the single biggest time saving for US-bound programmes.
04
An extra early-phase advantage
Investigational product for Phase 0 and Phase 1 trials does not need to be manufactured to GMP standard, which can remove a significant cost and time barrier for early studies. Australia provides a statutory exemption from formal local GMP licensing for Investigational Medicinal Products (IMP) used in initial experimental human studies.
05
Avion CRO’s role
We prepare and manage all submissions and notifications, so you never need to learn the system yourself.
Common Questions
The Clinical Trial Notification (CTN) scheme is Australia’s notification-based route for most clinical trials. Once a Human Research Ethics Committee approves the study, the trial is notified to the TGA rather than waiting on a pre-approval process like a US IND.
No. Trials conducted in Australia do not require a US FDA IND, which is often the single biggest time saving for programmes that would otherwise wait on the IND pathway.
HREC review is an efficient, well-understood process. Typical HREC timeframes from submission to approval take 4–8-week ethics and regulatory timelines via CTN pathway with rapid Study Start-up timelines of 3-4 months vs 8-9 months in US/EUR.
Avion CRO does. We prepare and manage all ethics submissions and TGA notifications on your behalf, so you never need to learn the Australian system yourself.
Two ways to work with us
Full-Service
Clinical Development
Every stage of your trial, from protocol to final report, delivered in-house by one scientist-led team.
Imaging Core Lab
& Radiopharma
Specialist imaging, dosimetry and radiopharmaceutical trial delivery, with the Imaging Core Lab inside the CRO rather than subcontracted. One team, one contract, faster decisions.