Europe – A vision for use of real-world evidence in EU medicines regulation

Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025: this is the vision of European regulators as outlined in an article from Peter Arlett, Head of Data Analytics and Methods at EMA, Jesper Kjær, Director of Data Analytics Centre at the Danish Medicines Agency, Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM), and Emer Cooke, EMA’s Executive Director, published in Clinical Pharmacology & Therapeutics.

The authors emphasise that delivering this vision, anchored in the Network Strategy to 2025, will support the development and use of better medicines for patients…