MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

10th May 2023

MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline.

The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These are anticipated to reach Step 2 soon and will be available for public consultation.

MHRA became a full member of ICH in May 2022. Whilst feedback on the ICH E6(R3) can be provided via the ICH website, MHRA wishes to consult directly with UK stakeholders to compile and co-ordinate their comments to the EWG. Please monitor the MHRA website for announcement of the consultation.

A MHRA GCP Stakeholder Engagement Meeting is also planned to be held concerning this document during the consultation period. Invitations to current contacts for this existing stakeholder engagement process will be sent out in due course. If your organisation has been part of previous meetings, please ensure that your contact details are up to date by contacting gcpstem@mhra.gov.uk.

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