EU – EU’s Action Plan for Real-World Data (RWD) & RWE

RWE 201 – EU – EU’s Action Plan for Real-World Data (RWD) & RWE


The European Union has embarked on an ambitious journey to weave Real World Evidence (RWE) into the fabric of its healthcare system. The strategy, underscored by a comprehensive multi-year plan, focuses on harnessing the power of real-world data (RWD) through collaboration, standardization, and innovation. The infrastructure for this integration outlines seven pivotal components: Terminology, Findability, Access, Quality, Advanced Analytics, Use, and Use Cases.


RWE 2020 – The Foundation: The EU emphasizes on the importance of RWD Collection and RWE Generation. Key pillars of this foundational year include:

– Enhancing collaboration nationally and across borders.

– Creating a robust framework with effective methodologies.

– Recognizing the role of RWE in supplementing clinical trials.

– Aiming to support decisions by regulators, HTA, and payers.

– Advocating support for healthcare providers.



– Focuses on access to RWD and the establishment of the EU4Health Program.

– Introduction of new legislations: Artificial Intelligence Regulation, Health Technology Assessment Regulation, and laws on RWE Value and RWD Access.

– Notably, a step towards centralized data governance with the European Health Data Space Regulation.



– Expands on the RWE Use Cases with guidelines and draft laws.

– Emphasis on medicinal product regulations.

– The Data Governance Act aims to support data access and streamline data utilization.



– Proliferation of RWE use cases continues.

– Medicinal Products Regulation is in the limelight alongside explorations into single-arm trials by EMA.

– The year marks a notable focus on AI with the EMA’s guidance on Artificial Intelligence.2024:

– The direction is set towards advanced RWD analytics and a broader scope of RWE Use Cases.

– Introduces a Catalogue of NIS using RWD Sources and a focus on RWD findability with source catalogues = The replacement for the EU PAS Register


This roadmap not only outlines the EU’s commitment to innovative healthcare solutions but also sets a precedent for global health systems to leverage real-world data and evidence for enhanced patient care.

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