We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
We are currently updating and restructuring our clinical trial webpages.
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.