European Medicines Agency

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.

These are some of the findings of a report published last month 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.

Overseen by the EMA-HMA Big Data Steering Group, EMA and EMRN are working towards setting up a sustainable framework that enables the use and establishes the value of RWE in decision-making across the entire product lifecycle.

Since the completion of an earlier pilot with the Pharmacovigilance Risk Assessment Committee (PRAC) in 2021, EMA has engaged in various pilots with its other scientific committees and working parties. The pilots aim to explore the need for and usefulness of RWE generated by EMA to support regulatory decisions. While the pilots continue, the report takes stock of the experience gained so far with regulator-led RWD studies. It focuses on studies conducted in addition to those performed in response to the COVID-19 public health emergency and the Pharmacovigilance impact strategy.

The report covers the period from September 2021 until the first anniversary of the Data Analysis and Real-World Interrogation Network DARWIN EU® on 7 February 2023. During this period, 61 RWD research opportunities were identified, 30 studies initiated and 27 completed.

The news announcement and the report has been published here.