Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, Communique, Meeting 4, 1 December 2025

The Therapeutics Goods Administration (TGA) hosted the fourth meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 1 December 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:

• Advertising requirements for clinical trials. Participants discussed:
  • Advertising guidance on biologicals
  • Compliance for promotional material
• The HREC Accreditation Scheme. We welcomed colleagues from the Clinical Trials Policy Section in Department of Health, Disability and Ageing, who presented updates on the Quality standards and accreditation for Human Research Ethics Committees. Participants discussed:
  • Consultation outcomes
  • Project timelines
  • HREC membership
  • The importance of local HRECs for clinical trials

The Forum will restart in 2026 with the next Forum anticipated for March/April.