Initiation of DARWIN EU® Coordination Centre Advances Integration of Real-World Evidence into Assessment of Medicines in the EU

On 9 February 2022 the EMA announced the establishment of the Coordination Centre with Erasmus University Medical Center Rotterdam for the 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 medicine 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 on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.

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