Consultation on the International Council for Harmonisation ICH M15 Guideline for Model Informed Drug Development (MIDD)
Consultation description
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.