EMA’s Fourth Real-World Evidence Report Shows DARWIN EU’s Role in EU Decisions

The European Medicines Agency (EMA) publishes an annual report on the real-world evidence (RWE) studies it initiates to support its own decision-making. The fourth report covers the period from 8 February 2025 to 7 February 2026. It describes how RWE is being integrated into regulatory work in line with the European Medicines Regulatory Network strategy to 2028, and it reviews the research questions that EMA committees asked during the year.

EMA generates its own RWE through two routes: the Data Analysis and Real World Interrogation Network (DARWIN EU) and studies commissioned under framework contracts. According to the report, 108 research topics were assessed during the period, 48 of them new, and the large majority (88%) were addressed through DARWIN EU. The report notes a shift towards feasibility-driven, higher-value questions, which has meant fewer new study topics being started than might otherwise be expected.

The report assesses the impact of completed studies. It states that 30% of studies directly supported a formal regulatory decision within an active procedure, and 44% improved clinical or methodological understanding relevant to regulators. The median time to complete a study was about five months, which the agency considers compatible with many, but not all, regulatory timelines.

These figures build on earlier years. In its third report, covering February 2024 to February 2025, EMA counted 59 RWE studies, with 33 completed and 26 ongoing, and described DARWIN EU as its primary pathway for generating RWE. The growth reflects the expansion of the network itself, which EMA reports has delivered around 110 studies since 2022 and had onboarded around 40 data partners by 2026. EMA’s DARWIN EU page refers to data on roughly 250 million patients.

Data partners convert their data into the Observational Medical Outcomes Partnership (OMOP) common data model, which allows the same analytical code to run across sources and shortens the time needed to answer a question. EMA revamped its DARWIN EU web page on 4 March 2026 to add summaries and visual abstracts of ten key studies, making the outputs easier for external readers to follow.

The DARWIN EU coordination centre began work in February 2022 and is run by Erasmus University Medical Center Rotterdam under contract to EMA. The agency opened a procurement procedure to select a framework contractor for the next phase of the coordination centre, with a deadline for submissions of 15 June 2026. The outcome of that procurement had not been confirmed in the sources reviewed for this brief.

EMA’s information material on its review of real-world data studies links this work to a wider Clinical Evidence 2030 vision, built on principles that include keeping patients at the centre, making use of existing data and maintaining transparency. Study protocols and results are listed in the HMA-EMA catalogues of real-world data sources and studies, which allows companies and researchers to see which questions regulators have investigated.

The scale of change since the programme began is considerable. EMA’s first review of regulator-led studies, covering September 2021 to February 2023, reported 25 studies initiated by the agency, of which only four were started through DARWIN EU. By the fourth reporting period, DARWIN EU had become the route for most research topics. The agency’s earlier information material set a target of more than 140 studies a year from 2025; the figures available for this brief do not show whether that target was met, and readers should rely on the report’s own figures rather than earlier projections.

For marketing authorisation holders, the main implication is that EMA committees increasingly have their own real-world data analyses available when they assess safety signals, disease epidemiology, drug utilisation or the context for a new medicine. A DARWIN EU study can inform a procedure even when the company has not submitted RWE itself. Companies should monitor the catalogues for studies on their products or therapeutic areas and be ready to respond to findings during procedures.

For applicants planning their own RWE, the DARWIN EU experience indicates the kinds of questions regulators consider answerable with routinely collected data, and the value they place on transparent protocols and standardised data models. Medical writers and epidemiologists can use published DARWIN EU protocols as reference points for study design, while noting that regulator-led studies serve the regulator’s questions and do not replace company obligations such as post-authorisation safety studies.