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The Therapeutics Goods Administration (TGA) hosted the second meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 1 May 2025.
The Forum is an open group for HREC chairs or their delegates and aims to provide a mechanism for collaboration between the TGA and HRECs. The Forum is not an advisory or policy decision-making group and is not a statutory committee of the TGA.
Presentations were made on:
- When is a clinical trial supply exemption required. Participants discussed:
- Challenges in choosing the appropriate supply exemption pathway in clinical research.
- Participants noted the various supply exemption pathways available to lawfully supply an unapproved therapeutic product, which are the Clinical Trial Notification (CTN), Clinical Trial Approval (CTA), Authorised Prescriber (AP) and Special Access Scheme (SAS).
- Clinical trials involving medical devices. Participants discussed:
- Challenges with clinical trials where unapproved medical devices are not the investigational product.
The next meeting is scheduled for August 2025.