Real-World Evidence Provided by EMA

The use of Real-World Data (RWD) in the development, authorization and monitoring of medicinal products continues to increase. EMA's newly published document on Real-World Evidence (RWE) explains

  • How RWE derived from analyzing RWD can be useful in the context of regulatory decisions,
  • What types of studies can be conducted,
  • What information gaps can be filled, and 
  • How the EMA can help identify the best resources to answer a research question.

An analysis of the available RWD by the EMA could help to fill knowledge gaps, to identify independent and transparent RWE sources or to carry out specific analyses tailored to the individual case, e.g. to support the work of EMA's scientific committees. Furthermore, evidence could be generated more quickly and the process steps that a marketing authorization holder (MAH) would have to comply with in order to have a corresponding study approved could be shortened. In addition, several products could be monitored at the same time, thus avoiding duplication.

Currently, scientific questions can be analyzed by the agency using three different RWE approaches:

  • DARWIN EU® (Data Analysis and Real World Interrogation Network)
  • Utilization of internal electronic health databases (from different EU countries)
  • Studies conducted under EMA framework contracts

Rapporteurs, assessors or representatives of national regulatory authorities could obtain additional information by submitting questions to the EMA that support the assessment of medicinal products. The document is therefore primarily aimed at regulators.

Moreover, in March 2024, the EMA introduced an AI-enabled knowledge mining tool called Scientific Explorer for EU regulators. The tool enables an easy, focused and precise search of regulatory scientific information from network's sources to support decision-making and simplify processes.

More information is available in the Guidance on Real-world evidence provided by EMA published on EMA's Big data website.

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