ERAMET Contributed to Draft ICH General Principles for MIDD Guideline
The coordinators of the ERAMET project have actively participated in the development of the Draft ICH General Principles for Model-Informed Drug Development (MIDD) guideline, which are now available on the International Council for Harmonisation (ICH) website. This contribution underscores ERAMET’s commitment to advancing innovative approaches in pharmaceutical research and regulatory science.
Model-Informed Drug Development (MIDD) is a cutting-edge strategy that leverages mathematical and statistical models to optimise drug development and regulatory decision-making. Through their expertise and research, ERAMET coordinators have played a key role in shaping the principles outlined in the draft guidelines, ensuring they reflect the latest scientific advancements and best practices.
The availability of these draft guidelines marks a significant milestone toward global standardization of MIDD approaches. Stakeholders across the pharmaceutical industry are encouraged to review and provide feedback to refine and strengthen these principles.
The ERAMET project’s involvement in this initiative highlights the importance of collaboration between industry, academia, and regulatory bodies in driving innovation and improving patient outcomes.
More information is available on the EMA website.