EMA Implementation of ICH E6, M11 & M12

The European Medicines Agency (EMA) has announced the implementation of various ICH (International Council for Harmonization) guidelines. Gaps that were previously covered by European documents will also be closed by supplementary papers. Moreover, the EMA has set up dedicated websites for the implementaion of the ICH E6, M11 and M12 guidelines.

ICH E6 - Good Clinical Practice (GCP)

The EMA has created a separate website for this guideline due to its relevance and the new approaches introduced by the revision. On this page, it explains the content, the new structure and the timeline for the further development of the guideline. The EMA launched a consultation process on the implementation of ICH E6 and published the comments received on Annex 2 of the ICH guideline.

ICH M11 - Clinical Electronic Structured Harmonised (CeSHarP) Protocol Template

The ICH M11 draft guidance includes the template for clinical study protocols and the technical specifications. Following the conclusion of the public consultation process on 22 April 2025 on the revised draft of the ICH M11 Technical Specification, an overview of the comments received has now been published on the EMA website.

ICH M12 Guideline on Drug Interaction Studies

The ICH M12 guideline will not completely replace the existing “EMA Guideline on the investigation of drug interactions - Revision 1”, as it does not address all the points covered by the EMA guideline. For this reason, the EMA has drafted a strategy paper that describes the topics for which the EMA "Concept paper on a guideline on investigation of drug interactions in the gastrointestinal tract" can supplement the ICH guideline in the future.