Clinical trials
Clinical trials involving therapeutic goods may be conducted in Australia under 2 schemes.
We are currently in the process of reviewing the CTA Scheme. More information at Review of Clinical Trial Approval Scheme.
Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants. We regulate the use of therapeutic goods supplied in clinical trials in Australia under the therapeutic goods legislation.
The following avenues provide for the importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in a clinical trial:
- Clinical Trial Notification (CTN) scheme
- Clinical Trial Approval (CTA) scheme.
Key information
For details go to Clinical trials and read the Australian clinical trial handbook.
Important information about clinical trials, including advice relating to COVID-19, is available on the Department of Health's clinical trial web page- external site.
Clinical trial processes - Information relating to COVID-19 provides clarification about the clinical trial process as it relates to COVID-19.
More information
- Investigator’s brochures for medical device clinical trials
- Video: Invoicing and the role of the Clinical Trials Repository
- Which clinical trial scheme should I choose?
- Clinical trial processes
- International scientific guidelines adopted in Australia
- EU and ICH guidelines not adopted in Australia
- Review of real world evidence and patient reported outcomes
Clinical Trial Notification (CTN) scheme
- FAQs on CTN online submissions and the clinical trials schemes
- Video: Creating and submitting a Clinical Trial Notification (CTN)
Clinical Trial Approval (CTA) scheme
Good Clinical Practice (GCP)
- ICH Guideline for Good Clinical Practice
- Good Clinical Practice (GCP) inspection program
- Good Clinical Practice Inspection Program: Frequently asked questions
- Webinar presentation: Information on the TGA Good Clinical Practice (GCP) Inspection Program, 9 May 2022
Forms
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The Metalyse (tenecteplase) shortage is now resolved.
Latest articles
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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.
Latest publications
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This guideline is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials