A panel of regulatory experts discussed how regulatory initiatives have advanced the use of real-world data (RWD) at this June’s Drug Information Association’s global meeting. The panelists, who came from the US Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), and Amgen, highlighted initiatives like the EMA’s Data Analysis and Real World Interrogation Network (DARWIN EU).
According to Joanne S Eglovitch, “DARWIN EU aims to provide EMA, the European Commission, and national competent authorities in the 27 member states access to the results of analyses of real-world healthcare databases. EMA recommended the establishment of DARWIN EU in January 2020. Currently, EMA has data partners in eight countries to supply data to DARWIN EU. The data partners are in the United Kingdom, Belgium, France, Spain, Finland, Estonia, Netherlands and Germany. EMA is currently selecting data partners for Phase 2 of the project.”
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(Source: RAPS, July 5th, 2023)