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Clinical trials

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.

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.

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