Revised ICH E6(R3) principles and Annex 1 published

The ICH E6(R3) principles and Annex 1 have been finalised and published on the ICH website. 

This is a rewrite and reorganisation of the previous version of the guideline on Good Clinical Practice (GCP), which sets international standards for clinical trials involving human participants. 

The update aims to apply GCP principles to the increasingly diverse trial types and data sources supporting regulatory and healthcare related decision-making on medicines, and provide flexibility, where appropriate, to facilitate the use of technological innovations in clinical trials.  

To ensure the guideline addresses the needs of all stakeholders, it takes into account feedback received through an extensive public consultation of the draft text and other channels, including a dedicated ACT EU workshop in 2023.  

To support stakeholders in the implementation of the revised guideline, ACT EU is organising a public workshop on the ICH E6 R3 revision on 19-20 February 2025.  

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, concluding on 28 February 2025.