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

22 juin 2023 – Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities. However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner. These are some of the findings of a report published today on the experience EMA has gained in conducting studies with real-world data (RWD) in the past year and a half. The report is part of the Agency’s efforts, alongside the European Medicines Regulatory Network (EMRN), to enable use of RWD in regulatory decision-making.

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