The renovation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline on Good Clinical Practice (GCP), aims to address the application of GCP principles to the increasingly diverse range of clinical trial types and data sources. It also provides flexibility, when appropriate, to facilitate the use of technological innovations in clinical trials.
ACT EU is focused on supporting the implementation of ICH E6(R3), including via dedicated workshops in liaison with the Multi-stakeholder platform and its advisory group.
The programme is also developing a communication and change management strategy to support smooth adoption and implementation of the revised guideline, in addition to updating the relevant EU guidelines impacted by the change.
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 is applicable in the European Union as of 23 July 2025.
EMA website: ICH E6(R3) Guideline for Good Clinical Practice - Step 5
Interactive training materials available on the ICH website:
Workshop report on ICH E6(R3) principles and annex 1
ACT EU hosted a multi-stakeholder workshop on the revised ICH E6(R3) guideline on 19–20 February 2025.
The event brought together patients, healthcare professionals, regulators, ethics committee members, industry, and academia to discuss the key changes introduced in ICH E6(R3), including its principles and Annex 1.
The full workshop report summarises the key messages, panel discussions, and stakeholder perspectives shared during the event.
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.
