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 - 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.
Quick links
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Access strategic plan: Updated for 2025-2028
The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies. -
Therapeutic Goods (Clinical Trial Notification Form) Approval 2024
This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. -
Proactive monitoring of highest-risk medical device clinical trials
We are reviewing the safety information supporting notifications of the highest-risk medical devices used in first-in-human clinical trials. Find out how the changes we have implemented impact you as a sponsor.
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This report provides an overview of pharmacovigilance inspection deficiencies in 2022, including a comparison to results from previous reporting periods.
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This guideline is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.