Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2

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 ICH Reflection paper on Renovation of Good Clinical Practice and the ICH E6(R3) Concept Paper and a Business Plan 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.

The Annex 2 concept paper was endorsed by the ICH Management Committee on 28 April 2023 and was published on the ICH website.

Annex 2 has now reached Step 2b and is available for public consultation.

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