Revised Good Clinical Practice Guideline ICH E6 (R3)

The revised International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), ICH E6(R3), will become effective in the EU on 23 July 2025. This update replaces the current version, ICH E6(R2), which was effective until 22 July 2025. 

The ICH E6(R3) Guideline  consists of the following components:

• Overarching principles and objectives
• Annex 1, which provides guidance for interventional clinical trials
• Annex 2, addressing non-traditional interventional clinical trial designs, is expected later in 2025

Key updates include:

• Introduces innovative provisions applicable for many types of trials to ensure relevance as technology and methods advance
• Encourages a risk-based and proportionate approach to trial conduct clinical trials
• Enhanced transparency by reporting clinical trial registration and results
• Additional guidance to support the informed consent process

The updated structure aims to improve clarity and usability for stakeholders including sponsors and investigators. 

Training requirements 

Training on ICH E6(R3) is considered essential to ensure compliance, data reliability, and participant protection. For more information on training expectations for sponsors, principal investigators and other delegated personnel based on their roles and responsibilities, visit the HPRA page on Good Clinical Practice.

Online training available

You can find a recording of a two-day training workshop coordinated by ACT EU in February 2025 on the ICH E6 revision.