Clinical trials involving therapeutic goods may be conducted in Australia under 2 schemes.
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.
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.
- Video: Invoicing and the role of the Clinical Trials Repository
- Which clinical trial scheme should I choose?
- Clinical trial processes
- EU and ICH guidelines not adopted in Australia
Clinical Trial Notification (CTN) scheme
- FAQs on CTN online submissions and the clinical trials schemes
- Video: Creating and submitting a Clinical Trial Notification (CTN)
Good Clinical Practice (GCP)
- ICH Guideline for Good Clinical Practice
- Good Clinical Practice (GCP) inspection program