ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6
The International Council for Harmonisation (ICH) recently announced that it is requesting public comment on a “Reflection Paper” outlining a proposed approach to revising and modernizing the ICH Guidelines for clinical trial design, planning, management and conduct. The planned modernization, which would affect the current E8 General Considerations for Clinical Trials and the E6 Guideline for Good Clinical Practice, addresses the increasing diversity of study types and data sources that are used to support regulatory and health policy decisions.
FDA helped draft the Reflection Paper and supports the effort. Stakeholders should submit comments firstname.lastname@example.org by March 11, 2017.
For more information, read the ICH press release.