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ICH E6(R3) Annex 2: Key Changes, Reflections, and How to Prepare

Written by Marianna Esposito | Mar 4, 2026 4:14:06 PM

The long-anticipated ICH E6(R3) Annex 2 draft, released on 6 November 2024, marks a significant step toward modernizing Good Clinical Practice (GCP) and addressing the growing complexity of clinical trials, including the integration of new technologies.  Since the  draft’s release for public consultation, comments have already been published on the ICH website, but the guideline’s final version and its effective date are still to be determined.