DIA Europe: EU regulators report steady progress in RWD acceptance
BASEL, SWITZERLAND – 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.”
He added that the agency is increasingly using RWD and said that “the discussion about [RWD] is a daily practice for us.”
BfArM is expanding its role beyond drug approval by launching the Health Data Lab (HDL). This initiative allows researchers to access real-world healthcare data from the statutory health insurance system, covering 73 million people in Germany.
The HDL combines data from prescription records, patient registries, electronic health records, inpatient statistics, and outpatient records to inform decisions regarding approvals, label expansions, and drug safety.
Verpillat similarly noted the growing recognition of RWD by EMA. He stated that the value of RWD is “increasingly being recognized by regulators” for its ability to transform and accelerate decision making. Utilizing RWD in clinical studies also “enhances the efficacy and design of clinical trials.”
Verpillat mentioned that from February 2023 to February 2024, the EMA received 60 new requests for research topics intended to generate real-world data to support regulatory decision-making, with 18 topics carried over from the prior period.
Out of these reports, 38 were triaged to the Data Analysis and Real World Interrogation Network (DARWIN), 16 were developed in-house, and 6 were contracted to other entities through framework contracts. Out of the research topics, 47 studies were found to be feasible.
He noted that most of the study requests were from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), Pediatric Committee (PDCO) and Scientific Advice Working Party (SAWP) committees. Most of the requests addressed questions on drug use, followed by drug safety, and epidemiology.
These studies have generated impactful information on drug safety, Verpillat said. For example, there was a recent study to assess the potential association between doxycycline use and suicide risk. The safety signal on suicidality was based on cases reported to the Finnish national competent authority and EudraVigilance.
EMA’s PRAC found that the available evidence does not support a link between the antibiotic and the risk of suicide, indicating that no update to the product information is necessary.
The DARWIN EU network has also grown in size to include 30 data partners and 39 data sources across 16 European countries.
EMA’s priorities this year include continuing to grow DARWIN EU and to focus on more specialized data sources, including data on special populations, rare diseases, and oncology. Another plan is to strengthen its outreach to data and registry owners to facilitate access to data for secondary use.
Clemente noted that the adoption of RWD has been a long journey, but she affirmed that "significant progress has been made” along the way.
She mentioned that there is a potential legislative "enabler" on the horizon that could enhance the acceptance of RWD.
This includes recital 60 of the proposed pharmaceutical reform regulation, which states that the authorization and supervision of medicinal products may be supported by health data analytics, including real-world data (RWD), when appropriate health data is generated outside of clinical studies.
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