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SP09-72: The Comparative Analysis of FDA and EMA’s Initiatives to Advance the Practice and Use of Real-World Evidence

Poster Presenter

      Arielle Dipasquale

      • PharmD Candidate, Class of 2021, Ernest Mario School of Pharmacy
      • Rutgers, The State University of New Jersey
        United States


The objective is to determine the scope, goals and recommendations of the FDA and EMA’s RWE initiatives and identify key similarities and differences in FDA and EMA’s key RWE considerations.


A cross-agency comparison was made based on the RWE strategy documents and meeting reports released within the past three years. FDA and EMA summary analyses were conducted in order to identify similarities and differences in terms of the scope, goals and recommendations.


An FDA summary analysis was conducted using the FDA’s Framework for RWE Program and Sentinel System Five-Year Strategy. While the Framework targeted a broad approach to the regulatory use of RWE, the current use of RWD for evidence generation is heavily supported by the Sentinel System. The scope of the Sentinel System focuses on creating a robust system using five aim strategies. Each aim focuses on areas regarding data, stakeholder knowledge sharing, safety analysis, and RWE generation in support of the Framework which focuses on three major components: whether the RWD is fit for use, whether the study design answers the regulatory question, and whether the study meets FDA’s current requirements. An EMA summary analysis was conducted using the EMA Regulatory Strategy to 2025 (EMA-RS 2025) Strategic Reflection and the HMA-EMA Joint Big Data Task Force Summary Report. The EMA-RS 2025 targeted a broad approach to advancing regulatory science, which included recommendations to develop the regulatory framework for emerging clinical data generation. The strategy document points to the Joint Task Force, which takes a more in-depth approach regarding data standards. The goal of the Task Force is to enable EMA to progress down the road to regulatory acceptability of RWD, with recommendations to implement uniform data standards, ensure data quality, facilitate secure data sharing, enable interoperability of data sources, and use novel analytical methods such as machine learning and artificial intelligence. Results showed that strategies of the FDA and EMA to enhance the use of RWD to generate RWE are significantly similar with minor discrepancies. EMA and FDA both agree to expand the external stakeholders involved, expand EHR access, implement analytical techniques for RWD, and implement data standards before RWD can be considered for regulatory use.


Real-world data has been collected to conduct safety surveillance for drug products through numerous platforms. However, the use of real-world evidence in regulatory decision making is limited due to the nature of real-world data that lacks standard methodologies to ensure data quality and control variability. Both FDA and EMA leverage platforms such as the Sentinel System and the Joint Big Data Task Force to improve access to high-quality data and utilize advanced technology and data analytics in order to draw meaningful conclusions from a large amount of data. Both agencies also aim to promote the use of RWD in regulatory decision making, such as fulfilling post-marketing commitments and generating evidence of product effectiveness. Opportunities exist for improving data standards, data sharing, data quality, data interoperability, and data analytics. External collaboration must continue to advance in order to promote shared learning and for meaningful advances in the use of RWD to be made. The hope is that by continuous collaboration and advancement of data standards and infrastructure, the full potential of RWD in regulatory decision making can be realized.