TGA hosted the seventh meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 13 October 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.
- Proposed TGA comments to Annex 2 of ICH E6(R3) Guideline for Good Clinical Practice.
- Consultations on modernising the clinical trials schemes and improving information sharing and transparency. Participants discussed proposals to:
- Align the Clinical Trial Notification and Clinical Trial Approval schemes legislation with current policy and practice.
- Prepare the framework for future technologies and planning for emerging regulatory risks.
- Improve information sharing across clinical trial stakeholders.
- An Update on New Approach Methodologies (NAMs). Participants discussed:
- The role of HRECs in the oversight and decision making in use of NAMs in clinical trials
The next series of Forums are currently in development. HRECs are invited to provide topic suggestions for discussion to clinicaltrials@health.gov.au and to lead future forum discussions.
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