Get a proposal

Regulatory timeline

HREC Ethics Approval Timeline in Australia

Australia requires no IND before an early-phase trial. With iNGENū’s managed pathway, HREC ethics approval is typically achieved in about 4 weeks, followed by a TGA CTN notification.

The ~4-week pathway, step by step

  1. 1Protocol & document readiness
    iNGENū prepares the HREC submission package — protocol, investigator brochure, ICF, and supporting documents — structured to the reviewing committee’s requirements.
  2. 2HREC submission
    The application is lodged with a registered Human Research Ethics Committee. Australia has no mandatory national regulator sign-off before starting — ethics review is the gate.
  3. 3HREC review & approval (~4 weeks)
    With a complete, well-prepared package, HREC approval is typically achieved in about four weeks.
  4. 4TGA CTN notification
    Under the Clinical Trial Notification (CTN) scheme, the trial is notified to the TGA — a notification, not a lengthy review.
  5. 5Site activation & first patient
    Sites are activated and dosing begins, materially faster than the US IND pathway.

Frequently asked questions

Ethics approval & start-up — FAQs

How long does HREC (ethics) approval take in Australia?
Australia has no mandatory regulatory review before starting; trials proceed via HREC approval plus a TGA CTN notification. With iNGENū’s managed pathway, ethics approval is typically achieved in about 4 weeks — materially faster than the IND route in the US.
Do I need an IND to start a trial in Australia?
No. Australia does not require an IND before an early-phase trial. Studies proceed under HREC ethics approval and the TGA Clinical Trial Notification (CTN) scheme, which is why start-up is among the fastest globally.
What is the difference between the CTN and CTX schemes?
Most trials use the Clinical Trial Notification (CTN) scheme, where the TGA is notified rather than conducting a pre-approval review. The Clinical Trial Approval (CTX) scheme involves TGA assessment and is used less commonly. iNGENū advises which pathway fits your trial.
How fast can I start a clinical trial in Australia?
Study start-up in Australia is among the fastest globally — no IND required, ethics in roughly 4 weeks, and site activation shortly after. iNGENū’s in-house regulatory and operations teams compress start-up further versus the US IND pathway.

Start your trial faster

Talk to our regulatory team about your ethics submission and start-up plan.

Request a proposal