The International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) Guideline has reached Step 2b and is available for public consultation.  As a clinical pharmacology assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I was involved with the development of this guidance.

The ICH Expert Working Group for ICH M15 (EWG) has produced the first draft of the ICH M15 MIDD guideline. The MHRA attended the EWG meetings.  A subgroup of members of the EWG was involved in preparing the ICH M15 guideline, the MHRA participated in the drafting group.  

The ICH M15 will provide general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD). It establishes a harmonized assessment framework (including associated terminology) for MIDD evidence. This was set out in the MIDD Discussion Group Roadmap and the M15 Concept Paper. A Business Plan was developed. ICH M15 is composed of a framework for assessment of MIDD evidence, model evaluation, MIDD reporting and submission, Glossary and Appendices. See the draft M15 guideline.

The M15 Concept Paper was endorsed by the ICH Management Committee on 10 November 2022 and was published on the ICH website.  

ICH M15 guideline has now reached Step 2b and is available for public consultation.

MHRA became a full regulatory member of ICH in May 2022, and whilst feedback on the ICH M15 guidance can be provided via the ICH website, MHRA is consulting directly with UK stakeholders to compile and co-ordinate their comments to the EWG.I encourage you to provide your comments, in the consultation, this should be done by submitting your comments via an uploaded Excel® spreadsheet. Please note we have also asked a few questions to obtain UK stakeholder views on whether ICH M15 MIDD guideline has realised the objectives set out in the concept paper for it.

https://medregs.blog.gov.uk/2025/01/10/ich-m15-model-informed-drug-development-midd-guideline/