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

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed 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 reflection paper is available for download 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.

The seeking of stakeholder comment on the current reflection paper is seen as a first step in an enhancement of the ICH process with respect to public consultation for the revision of ICH E8 and E6. The GCP Renovation reflection paper outlines additional steps that are also being considered to enhance stakeholder engagement.

Stakeholders are invited to submit any comments to gcprenovation@ich.org. All comments should be submitted before the closing date for public comment, which is March 11, 2017. ICH will review the comments received to determine whether to make revisions to the currently proposed approach. The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year.