International Council for Harmonisation (ICH) – The ICH E6(R3) Guideline reaches Step 4 of the ICH Process
ICH E6(R3) principles and Annex 1 have been adopted on 6th January 2025 and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. Further information can be found on the E6(R3) page, including the Guideline and the Step 4 Introductory Training Presentation. Annex 2 of the guideline is being developed in parallel. It provides additional GCP considerations focusing on examples of trials that incorporate decentralised elements, pragmatic elements, and/or real-world data. A draft of Annex 2 is currently under public consultation and will conclude on 28 February 2025.
News reported on the 31st of January 2025 in Catapult’s regulatory round-up, read the entire report here.
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adelage (20 mai 2025). International Council for Harmonisation (ICH) – The ICH E6(R3) Guideline reaches Step 4 of the ICH Process. ELSIBI. Consulté le 15 mars 2026 à l’adresse https://doi.org/10.58079/13yf4





