Real-World Evidence

Real-World Evidence (RWE) to revolutionize regulatory decision-making in medicine in Europe

In its latest report released in June 2023, the EMA highlights key opportunities and challenges to move towards an optimized usage of RWE across the spectrum of regulatory use cases. To push this transformative vision forward, the report presents a list of lessons learned and recommendations. Continue reading below.


In its network strategy to 20251 published in 2021, the European medicine agencies set out how they aim to collectively tackle current and future challenges more effectively in the next 5 years. One of the focus areas identified relates to data analytics, digital tools, and digital transformation. A significant role goes to the potential of leveraging Real-World Data across the EU for better regulatory decisions and improved health promotion and enhanced public health. This in turn fits within the European medicine agencies’ wider purpose to contribute to the European Health Data Space.

Various challenges (or rather opportunities?) to have this transformative vision work were identified in the strategy report ranging from the complexity of big data to the need to maintain public and stakeholder trust beyond data protection legislation.

Below we take a closer look at the regulatory framework the European Medicines Agency (EMA) is creating to facilitate the use and to establish the value of RWE in decision-making throughout the drug development lifecycle. The establishment of DARWIN EU in February 2022, an initiative led by the EMA, is set to be key in contributing to this vision.

Towards an optimized usage of RWE across the spectrum of regulatory use cases

In their latest report released in June 2023, the EMA evaluated the opportunities and challenges in supporting regulatory decision-making with RWE.2 It takes a closer look at the regulator-initiated RWD studies performed from September 2021 to February 2023, which covered a wide range of areas including safety, drug utilization, disease epidemiology, and clinical trial design.

Lessons Learned

First lessons learned included among others, the effectiveness of RWD studies in supporting a wide range of research questions and driving decision-making across various regulatory contexts and procedures; and the importance of a good understanding of data provenance, quality and completeness and other data source characteristics to assess the strengths and limitations of RWD studies. Approximately one-third of research studies in 2022 were not feasible due to conditions not diagnosed or medicines not used in primary care setting.


To propel the transformative vision forward, the report provided an extensive list of recommendations, including wider access to diverse data sources, accelerating RWE generation, better and earlier identification of research needs, capacity building for RWE generation, and collaboration with stakeholders.

These findings will (further) shape the work of the Big Data Steering Group and the establishment of DARWIN EU. As we move towards 2025, further efforts will be required to enable the use of RWE across regulatory use cases in the European Union. Together, we can fully leverage the potential of RWE and improve health for all.






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