We are pleased to share information about a new EMA guideline on the clinical investigation of medicinal products for the treatment and prevention of diabetes mellitus. This revised guideline, effective from 1 January 2024, replaces the previous 2012 guideline and reflects the current European Union regulatory stance on key issues in developing new treatments for type 1 and type 2 diabetes.

The primary motivation for the update was to enhance the section on cardiovascular safety, incorporating insights from the 2016 reflection paper on assessing the cardiovascular safety profile of medicinal products. Additionally, the revision aimed to address other evolving topics in the diabetes field that required clarification according to the EMA and other stakeholders.1

You can access the guideline here.

References

  1. Clinical trials in human medicines | European Medicines Agency. (n.d.). https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred