Consultation: Proposed TGA Annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month Transition Period

Overview

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.

Timeframes

ICH E6(R3) Guideline for GCP: Principles and Annex I with TGA annotations are expected to be adopted in January 2026. To support implementation, a 12-month transition period is proposed, allowing sponsors, trials sites and other stakeholders time to meet the updated requirements. The timelines provided are indicative. Following the consultation and consideration of stakeholder feedback, the key adoption and transition dates will be announced on our webpage ICH Guideline for Good Clinical Practice and promoted on our social media. 

Read the proposed TGA annotations

• Consultation paper: Proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I (pdf)
• Consultation paper: Proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I (word)

How to respond

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• Please submit your feedback using this platform.
• Email submissions are not required. 

Closing date: close of business 10 October 2025.