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

We asked for feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period to ensure consistency with Australian legislative requirements for clinical trials involving unapproved medicines and biologicals under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.

We received 51 submissions in response to the consultation. Respondents provided a range of suggestions to improve the annotations and topics for guidance, with most supporting the 12-month transition period. We appreciate all the feedback received.

We considered all feedback received and made changes to the annotations. We have adopted ICH E6(R3): Principles and Annex I, which will take effect on 13 January 2026 and mark the start of a 12-month transition period. For more information see ICH Guideline for Good Clinical Practice.  

Changes we made in consideration of feedback included:

• Updating the introduction to make it clearer that TGA comments are prepared to assist stakeholders in complying with ICH E6(R3) in accordance with local regulatory requirements.
• Including a link to the other guidelines adopted by the TGA to assist stakeholders in complying with ICH E6(R3).
• Citing specific chapters and paragraphs in the National Statement that address special cases of informed consent, including guidance on obtaining valid consent where individuals lack capacity and on alternative pathways for recruiting participants
• Specifying the period for which records should be retained is determined by applicable state, territory and/or national law, together with prevailing standards for the specific type of research.
• Clarifying that permanent retention periods may apply for certain trial types.
• Providing details to support the National Statement requirements for trial registration and the timely dissemination of trial results.
• Minor changes including clarification of ambiguous phrasing and grammar, punctuation and/or formatting.

We appreciate your suggestions for future guidance topics. They have been noted and will help inform the focus of our educational resources.