The European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Health Canada (HC) have agreed on terms of reference for a trilateral cluster on Real-World Data (RWD), according to a document published by EMA on 17 July 2026. The cluster aims to support regulatory decision-making through information sharing and the development of new approaches for assessing evidence derived from RWD or other big data sources, with the goal of fostering consistency across jurisdictions and resolving common challenges.
The collaboration will focus on scientific methods for collecting, transforming, and analysing RWD, particularly in regulatory use cases where experience is limited, such as evaluating efficacy. The agencies will coordinate collaborative work where sharing information, results, or conclusions may be mutually beneficial, including validating methods developed in one jurisdiction using different types of RWD available in another. They will also identify specific data sets, projects, or networks where trans-Atlantic collaboration could add value, such as converging approaches for specific registries. Upstream regulatory convergence, for example in developing key principles or guidance, is another objective.
The cluster will hold monthly one-hour teleconferences, chaired by each agency on a rotating basis, with ad-hoc meetings possible on policies, guidance, or scientific methodologies. Topics will be selected based on major relevance to all three agencies and must meet the stated objectives. The agency proposing a product discussion should first liaise internally with other regulators' clusters to avoid overlap. Additional participants from the agencies may join depending on the topic.
Confidentiality arrangements between the parties will govern the work, and observers from other regulatory authorities may participate subject to appropriate confidentiality agreements. The cluster does not have a fixed workplan but maintains a rolling list of topics that can be updated as needed.
This initiative impacts pharmaceutical companies, which may face evolving expectations for RWD submissions across jurisdictions, potentially increasing compliance costs but also offering clearer guidance. Patients could benefit from more efficient regulatory decisions informed by broader real-world evidence. National regulatory authorities in the EU may need to align with EMA's approaches, while the agencies themselves stand to gain from shared expertise and reduced duplication of efforts.