The European Medicine Agency has recently published a document that describes its strategy until 2025:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf
The EMA proposed strategy recognizes the importance of emerging technologies in general and modelling and simulation, also known as in silico methods, in particular. However, the document tends to stress the value of
in silico methods almost exclusively in connection with the reduction of animal experimentation. While we agree that this is a relevant application for such methods, it is not the only one and likely not the most impactful one for the patient and for the industry.
The term In Silico Trials indicates a number of use cases, not only related to pre-clinical evaluation, but also to the reduction, refinement, and in some cases even replacement of clinical trials.The VPH Institute together with the Avicenna Alliance, the Insigneo Institute for in silico Medicine and the Alma Mater Studiorum, University of Bologna has drafted an open letter, which will be sent to Prof Guido Rasi - the Director of EMA to raise our collective voices on this regard.
