ICH E6(R3): A Major Evolution in Good Clinical Practice!

Long awaited, the ICH officially adopted version R3 of ICH E6 on January 6, 2025.

The text will apply at the European level from July 23, 2025, and can be viewed/downloaded below:

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r3-guideline-good-clinical-practice-gcp-step-5_en.pdf

To accompany this new publication, the ICH provides an analysis of the changes between versions R2 and R3:

https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step%204_Presentation_2025_0123.pdf

What’s new? What are the impacts? What actions are needed?

We work with you to ensure a successful transition, reassess your risks, and maintain the compliance of your studies!