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Clinical trials

Clinical trials involving therapeutic goods may be conducted in Australia under 2 schemes with different notification and approval processes.

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 - external site websiteAustralian clinical trials - external site 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.

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