ICH News!! (Good Clinical Practice Guideline E6(R3))
The International Council for Harmonisation (ICH) has today (14 January) announced the adoption of the final version of its Guideline for Good Clinical Practice E6(R3). This update is a major milestone in global clinical research, reflecting the latest thinking in ethics, science, and quality standards.
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
This update replaces E6(R2) and aligns with ICH E8(R1) principles to foster quality by design, making clinical trials more adaptable to emerging technologies and diverse participant populations.
Next Steps: The ICH E6(R3) guideline is now recommended for adoption by regulatory bodies across ICH regions, setting the stage for harmonized global implementation in clinical trial practices.