Europe’s regulatory system for medicines can be used more effectively

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the current regulatory system for medicines in the Europe Union could be used in more efficient and effective ways.

Andre Broekmans, Escher’s chairman, explained: "Overall, the EU regulatory system operates well, however important recent changes had not been evaluated until now. One of our report's conclusions is that pathways originally intended to bring important new medicines to market faster are not being used in the right way. We are therefore missing opportunities to make medicines available to patients earlier."

Escher collaborated with researchers from Utrecht University to look into a number of areas that might be improved, namely pharmacovigilance, conditional approval, pediatric investigation plans and decentralized authorization procedures. The research shows that some parts of the regulations are not yet fully achieving the effects they were intended to have.