4 December 2024 – Swissmedic has announced the launch of the public consultation on the ICH Guideline M15 «General Principles for Model-Informed Drug Development» (MIDD) in Switzerland. Stakeholders are invited to submit comments on the draft guideline by 28 February 2025. The guideline aims to establish general principles and best practices for the use of MIDD, promote standardized documentation requirements, and harmonize the evaluation of data quality and the robustness of analyses. This will facilitate a common understanding among multidisciplinary scientists within and between regulatory authorities and the industry. Additionally, the guideline seeks to standardize the integration of MIDD into regulatory decision-making processes.

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