Clinical trials
Clinical trials involving unapproved therapeutic goods may be conducted in Australia under 2 schemes: Clinical Trial Notification or Clinical Trial Approval.
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.
Contact us and keep updated
Contact details
Email: clinical.trials@health.gov.au
If your enquiry is not specifically about clinical trials conducted within the CTA or CTN schemes, please contact our TGA info team.
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653
Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 020 653.
Quick links
Latest articles
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Updated classification rules for certain combination products
Updated classification rules for non-invasive medical devices that are used to maintain the patency or flush the lumen of another medical device. -
Clinical decision support system exemption amendments
We have amended the Clinical Decision Support System (CDSS) exemption to provide greater clarity about when the exemption applies. The amendments come into effect from 1 November 2026. -
Access strategic plan: Updated for 2025-2028
The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.
Latest publications
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Communique from the 6th meeting of the Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, 14 July 2026.
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Communique from the 5th meeting of the Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, 13 April 2026.
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Communique from the 4th meeting of the Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, 1 December 2025