Consultation: Proposed TGA Annotations to ICH E6(R3)

2nd September 2025

This consultation invites feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period. 

On 6 January 2025, the International Council for Harmonisation (ICH) endorsed the third revision (R3) of the ICH Guideline for conducting clinical trials titled ICH E6(R3) Guideline for GCP. This update addresses changes in trial design and technological innovations, and strengthens a proportionate, risk-based approach to the design and conduct of clinical trials.

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible. TGA annotations to the ICH E6(R3) Guideline for GCP ensures consistency with Australian legislative requirements for clinical trials of unapproved medicines and biologicals under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.

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