Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
Detail of outcome
The MHRA has used the responses to the consultation to deliver feedback from UK stakeholders to the International Council for Harmonisation (ICH). Details and further updates can be found on the .
Original consultation
Consultation description
The update of ICH E6 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 regulatory and healthcare decision making.
This was set out in the and the and a was developed.
ICH E6(R3) has been restructured and is composed of an overarching principles section, Annex 1 (interventional clinical trials), Annex 2 (additional considerations for non-traditional interventional clinical trials), Glossary and Appendices.
The overarching principles, Annex 1, Glossary and Appendices will replace the current E6(R2) and were released for public consultation by ICH in May 2023.聽
The was endorsed by the ICH Management Committee on 28 April 2023 and was published on the ICH website.聽聽
has now reached Step 2b and is available for public consultation.
Updates to this page
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Response to consultation published.
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First published.