EMA’s plan to integrate real-world data across Europe

EMA to promote use of real-world data in regulatory decision-making via DARWIN

One of EMA’s top priorities for incorporating real-world data earlier in the regulatory process is establishing DARWIN, a centralized system that would enable it to obtain harmonized data from healthcare systems across Europe.

RWD is often used to assess drug safety and efficacy in post-marketing studies, but its use in premarket regulatory decisions has lagged, due in part to the quality of data generated from observational studies or routine care, and to the fragmented systems and variable methods used to collect the data.

The promise of RWD in marketing authorization decisions is large, however, as it could offer knowledge that is more relevant to patients and physicians than standard clinical trials, help identify new indications for approved therapies, and enable natural history or synthetic control arms

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