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The European Medicines Agency (EMA) is establishing a Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®). The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.

The vision of DARWIN EU® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.

DARWIN EU will support regulatory decision-making by:

  • establishing and expanding a catalogue of observational data sources for use in medicines regulation;
  • providing a source of high-quality, validated real world data on the uses, safety and efficacy of medicines;
  • addressing specific questions by carrying out high-quality, non-interventional studies, including developing scientific protocols, interrogating relevant data sources and interpreting and reporting study results.

The range of approved healthcare databases enabling distributed data access via DARWIN EU will evolve and expand over time.

More information: DARWIN EU ® website


Posted on

April 8, 2022