Twenty years ago, the International Council for Harmonisation (ICH) drafted the Guideline for Good Clinical Practice (GCP), ICH E6, an international ethical and scientific quality standard for clinical trials. Since then, the complexity of clinical trials has increased significantly, and ICH E6 has been revised to reflect changes in emerging technology and evolving trial designs.
The latest revision, ICH E6(R3), published in January 2025, builds upon GCP by further emphasizing the importance of proactively fostering quality culture in clinical trials and drug development planning.
The European Medicines Agency (EMA) adopted ICH E6(R3) in July 2025, and the U.S. Food & Drug Administration (FDA) published the guidelines in September 2025. In the UK, MHRA implementation aligned with the amended Clinical Trials Regulations, which took full effect on . With this official rollout by global regulators, it’s imperative that investigators are prepared for the transition from ICH E6(R2) to ICH E6(R3).