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The Therapeutics Goods Administration (TGA) hosted the third meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 13 August 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:
- HRECs and the Authorised Prescriber (AP) Scheme. Participants discussed:
- HREC oversight of APs, including monitoring the submission of mandatory reports to the TGA or other reports required by the HREC
- Liability, insurance and indemnity considerations for the AP scheme and the compassionate use of drugs following the completion of a trial
- The current consultation on reviewing the safety and regulatory oversight of unapproved medicinal cannabis products.
- Insights into Good Clinical Practice (GCP) Inspection Program activities 2023-2024. Participants discussed:
- The positive value of GCP inspection reports for HRECs
- The importance of recording HREC reasoning and decisions when approving clinical trial documentation.
The next meeting is scheduled for November 2025.