An EU review shows the great potential of regulator-led real-world evidence studies to address a range of research questions for regulatory decision making. It also provides learnings and recommendations for future improvements to the RWE framework being drawn up by the European Medicines Agency alongside the European medicines regulatory network.

A two-year pilot will explore the many potential benefits that the analysis of raw data can bring to the EU drug evaluation process. These range from faster patient access to medicines, companies facing fewer questions, and better definition of the target treatment population.

An EU-wide network of real-world data sources will aim to become the dominant vehicle for delivering such evidence to the EMA and member countries, who have until now been using a wide range of different sources to access such data.