The International Council for Harmonisation (ICH) has adopted Annex 2 of ICH E6(R3): Good Clinical Practice, concluding the revision of this essential ICH Guideline. 

ICH E6: Good Clinical Practice (GCP) is an internationally recognised, ethical, scientific and quality standard for the conduct of clinical trials that involve human participants. Clinical trials conducted in accordance with this standard help to ensure that the rights, safety and well-being of trial participants are protected and that the clinical trial results are reliable. 

ICH E6 is one of ICH’s three foundational Tier 1 Guidelines and therefore an implementation requirement for any regulatory authority wishing to become an ICH member. 

In the two decades since the Guideline was first drafted, clinical trials have become more complex with respect to trial design, use of technology, quantity of data collected and involvement of central testing facilities or other service providers. The latest revision, ICH E6(R3), addresses the complexities of clinical trials in the current global regulatory climate and builds on key concepts outlined in ICH E8(R1): General Considerations for Clinical Studies. 

ICH E6(R3), comprising the Principles, Annex 1 and Annex 2, was adopted in two stages. The Principles and Annex 1 were adopted on 6 January 2025, introducing a flexible, risk-based framework for interventional clinical trials that accommodates a modern approach to the design and conduct of clinical trials. Annex 2 was subsequently adopted on 3 June 2026, providing additional GCP considerations tailored to the evolving clinical trial landscape, covering decentralised elements, pragmatic elements and the use of real-world data. Because Annex 2 builds on the foundations established in the Principles and Annex 1 and is not intended to be read in isolation, all three have been consolidated into a single unified ICH E6(R3) guideline. 

Although Annex 2 is not intended to be read as a standalone document, given that some National Regulatory Authorities had begun implementation of the Principles and Annex 1 prior to the publication of Annex 2, ICH will temporarily also make Annex 2 available as a separate document until the end of 2026.