The initiative aims to support the modernisation of good clinical practice in order to align with the increasingly diverse range of clinical trial types and data sources.
This will support the implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline.
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;
- provide flexibility to facilitate the use of technological innovations in clinical trials.
The revised guideline will be applicable in the European Union as of 23 July 2025.
ICH website: ICH E6(R3) Guideline for Good Clinical Practice - Step 5
Public consultation on ICH E6(R3) Annex 2
The public consultation on the draft ICH E6 (R3) Annex 2 concluded on 28 February 2025.
Annex 2 addresses GCP considerations for trials with decentralised elements, pragmatic elements, and real-world data. It should be read along with the ICH E6 (R3) Principles and Annex 1.
