Consultation: Proposed TGA comments to Annex 2 of ICH E6(R3) Guideline for Good Clinical Practice (GCP)

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed TGA comments to Annex 2 of the ICH E6(R3) Guideline for Good Clinical Practice (ICH GCP E6(R3)). TGA comments explain Australian-specific considerations that should be taken into account when applying the guideline.

We are also seeking feedback on the proposal not to provide a transition period for sponsors, trial sites, and other stakeholders, as Annex 2 does not introduce any new requirements, and instead provides additional supporting guidance.

Timeframes

Following consideration of consultation feedback, the TGA intends to adopt the consolidated ICH GCP E6(R3) guideline in January 2027. TGA comments to Annex 2 will be published on the TGA website alongside the existing comments to the Principles and Annex 1.

Further information, including the published TGA comments to the Principles and Annex 1, is available at ICH Guideline for Good Clinical Practice. 

Read the consultation paper

• Proposed TGA comments to Annex 2 of ICH GCP E6(R3)
• Annex 2

How to respond

To provide feedback, click ‘Submit My Feedback' below.

We invite you to submit feedback through this online platform by close of business 20 November 2026. Email submissions are not required.