Adoption of ICH E6 (R3) is Coming

In May 2023, the International Council for Harmonisation (ICH) released the third revision of the Good Clinical Practice E6 guidelines, replacing the E6 (R2) released in 2016. Currently, the document is published for public consultation.

The purpose of this revision is to modernize the way clinical trials are performed and to keep pace with the latest innovations, such as electronic systems, complex trials, and risk- and quality-based considerations for the protection of patient safety and data integrity.

ICH E6 (R3) actually contains 3 sections:

• 1. Principles
• 2. Annex 1
• 3. Annex 2

Annex 2 is expected to appear in the middle of 2024 again for public consultation, and the whole document should be approved somewhere in 2025. Until then, ICH E6 (R2) remains the live, valid, and applicable GCP guideline.

Revision 3 is significant, with a strong emphasis on risk management and quality. The main GCP principles have been revised and reduced in number from 13 to 11. Roles and responsibilities of both sponsors and investigators have been revised, and annexes have been introduced, which will make adding new information easier in the future.

Key stakeholders in clinical trials are encouraged to review the draft and understand the key changes. The document is still not adopted, but it is a good time to plan ahead and commence change initiatives.