Planned website maintenance is taking place from 11:00 pm AEDT on Friday 30 October to 6:00 am AEDT on Saturday 31 October 2026. Some pages may be temporarily unavailable. If issues continue outside this time, please contact us.
We are currently updating and restructuring our clinical trial webpages.
Consultation:
The Therapeutic Goods Administration (TGA) is seeking feedback on new approaches to information sharing under the clinical trial schemes.
We invite comments through the Consultation hub by close of business 20 November 2026.
Australian clinical trials are subject to regulation by us to ensure the safe use of unapproved goods for experimental purposes in humans. We regulate the use of therapeutic goods supplied in clinical trials in Australia under the therapeutic goods legislation.
The Australian clinical trial handbook provides guidance to clinical trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions).
Information about clinical trials for consumers, health care providers, researchers, industry and sponsors is available on the National Health and Medical Research Council's (NHMRC) Australian clinical trials websiteAustralian clinical trials website.