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MHRA opens consultation on ICH M15 guideline for Model Informed Drug Dev

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Published on: 10 January 2025

Published by LNB News

LNB News 10/01/2025

Document Information

Issue Date: 10 January 2025

Published Date: 10 January 2025

Jurisdiction(s): England, Northern Ireland, Scotland and Wales

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on the International Council for Harmonisation (ICH) M15 guideline for Model Informed Drug Development (MIDD). The guideline, which has reached Step 2b in the ICH process, aims to establish a harmonised assessment framework for MIDD evidence, including recommendations for planning, model evaluation, and documentation. The MHRA participated in the drafting process and is now seeking input from stakeholders until 31 March 2025.

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