EMA Leans into Push to Improve Real-World Data Sources for Regulatory Decision-Making

Officials from the European Medicines Agency (EMA) and member state national health technology assessment (HTA) agencies recently announced they were going forward with plans to improve the quality of real-world data (RWD) resources for use in regulatory decision-making. The EMA and HTA bodies established a Big Data Steering Group, which has already endorsed documents that will go through a phase of public consultation.

According to the EMA, “Data quality is a critical element for realising the full potential of data-driven regulation and supports the trust of patients and healthcare professionals. The draft Data Quality Framework for EU medicine regulation, now open for public consultation, sets out quality criteria for data used in medicine regulation to ensure they are fit for purpose to support benefit-risk decisions.”

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(Source: EMA, October 10^th, 2022)