ICH - ICH E6(R3) Principles, Annex 1 and Annex 2

23rd May 2023

ICH

The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation” on the ICH Reflection Paper page. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2.

While the original E6(R3) Concept Paper stated that before the drafting of Annex 2, its scope would be further clarified, to define the nature of trials involved, in an update to the Concept Paper, the EWG subsequently determined that a separate Concept Paper was preferred for Annex 2. Further to this, an Annex 2 Concept Paper was approved in May 2023 by the ICH MC, and an E6(R3) EWG Annex 2 Sub-group was established to begin development of Annex 2.  

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