Use of real-world evidence in regulatory decision making – EMA publishes review of its studies

June 23, 2023

The European Medicines Agency (EMA) has released a review highlighting the use of real-world evidence (RWE) in regulatory decision-making. Real-world evidence refers to data collected outside of traditional clinical trials, such as from observational studies, patient registries, and electronic health records.

The review demonstrates the EMA's commitment to harnessing the potential of RWE to support regulatory assessments and decision-making processes. It emphasizes the importance of robust methodologies, data quality, and transparency in utilizing real-world evidence effectively.

The EMA acknowledges the value of RWE in complementing clinical trial data, especially in areas such as safety monitoring, effectiveness evaluation, and understanding the real-world impact of treatments. The review provides insights into the EMA's ongoing efforts to promote the use of real-world evidence, ensuring that regulatory decisions are evidence-based, patient-centered, and reflect the real-world healthcare setting.


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