Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines

The ICH Expert Working Group (EWG) for ICH E6(R3) has been updating ICH E6(R2) GCP guidelines. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG. The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support…

Consultation description The ICH Expert Working Group (EWG) for ICH E6(R3) has been updating ICH E6(R2) GCP guidelines. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG. The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines…