Stakeholders in Switzerland have the possibility to comment on the draft of Guideline M15 “General Principles for Model-Informed Drug Development” until 28 February 2025.
Many regulatory authorities expect to receive – and currently accept – model-based analyses as part of dossier submissions. However, the lack of common documentation standards, model assessment expectations and understanding of concepts/principles hinders assessment of the quality of the data used, the robustness of the analysis vis-à-vis the modelling impact and credibility with respect to its intended applications. As a result, the level of integration of MIDD into regulatory decision-making can vary between regulatory authorities, from application to application and within authorities for the same or similar submissions.
The new overarching ICH M15 MIDD General Principles Guideline will broadly cover the general principles and good practices for the use of MIDD. The guideline will establish a common understanding across multidisciplinary scientists, both within and between regulatory authorities and industry. Additionally, the guideline will harmonise expectations regarding documentation standards, model development, data used in analysis, model assessment and its applications.
Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working group and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page: