Article
CRO · Regulation · 6 November 2026
The International Council for Harmonisation (ICH) has revised its guideline for Good Clinical Practice, E6, for the third time. The overarching principles and Annex 1 of E6(R3), adopted by ICH and by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, came into effect on 23 July 2025.
The revised guideline is organised differently from its predecessor: a set of principles that apply to interventional clinical trials, and annexes that explain how to apply them. Annex 1 covers the conduct of trials and the roles of ethics committees, investigators and sponsors.
Annex 2 adds considerations for non-traditional interventional trials: pragmatic trials, decentralised trials and trials that incorporate real-world data sources. ICH adopted it on 3 June 2026 and the CHMP on 25 June 2026. It comes into effect on 15 January 2027.
Across the guideline, the emphasis is on quality by design and on a proportionate, risk-based approach to the conduct and oversight of a trial.
Study teams planning trials with remote elements, home visits or data from routine care may want to review their procedures against Annex 2 before it applies.
Source: European Medicines Agency — ICH E6 Good clinical practice
