DIA Europe: EU regulators report steady progress in RWD acceptance
- kenashman
- May 8
- 1 min read
Regulatory News: 21 March 2025 Joanne S. Eglovitch
Regulators and a representative from the pharmaceutical industry discussed the increasing acceptance of real-world data (RWD) in regulatory procedures in the EU during a panel discussion at DIA Europe 2025 on Wednesday. They emphasized the importance of RWD in informing decision making for new drug approvals and improving drug safety data collection.
The session included Karl Broich, president of Germany’s Federal Institute for Drugs and Medical Devices (BfArM) in Germany, Patrice Verpillat, head of real-world evidence at the European Medicines Agency (EMA), and Amaia Clemente, associate director of regulatory science and policy EU/AMEE.
Broich said his agency used to be a “classical regulatory body” whose sole purpose was to evaluate the safety and efficacy of new drugs. Germany’s healthcare technology assessment bodies also used to take a “highly conservative approach” to using real-world data in Germany. This outlook has “has changed over the years,” he said, “A few years ago we were told that we would never use real-world data for regulatory purposes, today it is much better.”
