Pharma Lessons is Getting Ready for the Adoption of ICH E6 (R3)
Summary
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. Annex 2Annex 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. 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.Pharma Lessons is preparing for the arrival of the new update and working on a brand new GCP course.