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Our consultation on the draft of the International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) guideline closes on Monday, 31 March 2025.
The ICH Expert Working Group for ICH M15 (EWG) has developed the ICH M15 MIDD guideline. The MHRA attended the EWG meetings.
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 harmonised 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. The draft M15 guideline can be accessed here.
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.
Find out more and share your views here.
The consultation will close on Monday, 31 March 2025.
Please share this email with your networks and contacts so that we can get the broadest possible response.
Thank you for your support.
Kind regards,
Medicines and Healthcare products Regulatory Agency
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