Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, Communique ,Meeting 5, 13 April 2026

The Therapeutics Goods Administration (TGA) hosted the fifth meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 13 April 2026. 

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: 

• Understanding Good Manufacturing Practice (GMP) requirements for the manufacture of therapeutic goods used in clinical trials. Participants discussed: 
• GMP considerations for devices 
• How GMP is considered within HREC review processes

The Next forum is anticipated to be held in July 2026. HRECs are invited to provide suggestions and to lead future forum discussions.