New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus

Excerpt

The European Medicines Agency (EMA)’s revised guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus took effect on 1 January 2024, replacing the previous guideline from 2012 [1, 2]. The guideline is intended to address the current European Union regulatory position on the main topics of importance for the clinical development of new medicinal products in the treatment or prevention of type 1 and type 2 diabetes. One of the main reasons for revising the previous guideline was to update the section on cardiovascular safety, which was addressed in greater detail in the 2016 reflection paper on the assessment of the cardiovascular safety profile of medicinal products [3]. However, the diabetes field has evolved rapidly over the last decade and the revision also presented an opportunity to address other topics that, in the view of EMA or other stakeholders, warranted clarification. …