The International Council for Harmonisation (ICH) Expert Working Group for ICH M15 (EWG) has been updating the ICH M15 General Principles for Model-Informed Drug Development (MIDD) guideline. The UK Medicines and Healthcare products Regulatory Agency (MHRA) is seeking comments on behalf of ICH M15 EWG in the United Kingdom geographical region.
The guideline 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 will be composed of a framework for assessment of MIDD evidence, model evaluation, MIDD reporting and submission, Glossary and Appendices. See the draft M15 guideline.
We invite UK stakeholders and other ICH members to complete the consultation. Following the consultation, the feedback will be reviewed and discussed by the ICH M15 EWG.
We do not intend to publish a full response to this consultation.
The consultation closes at 11:59pm on Wednesday, 31 March, 2025.