ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

The reflection paper on Good Clinical Practice (GCP) "Renovation" contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).

The E8(R1) Concept Paper and Business Plan are available via the following link:


 The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. The underlying principles of human subject protection and data quality would remain. ICH’s decision to invite stakeholder comment on the proposed renovations at this early stage, ahead of guideline development efforts, recognises the considerable stake and relevant expertise in the research community beyond ICH.