skip to main content
European Commission Logo
en English
Newsroom

Overview    News

DARWIN EU® continues to scale up in its second year of establishment

DARWIN EU® is in the process of onboarding ten additional data partners to expand its capacity to deliver real-world evidence-based studies. These studies provide valuable insights to support regulatory decision-making throughout the lifecycle of a medicinal product.

date:  14/12/2023

Following the set-up of the DARWIN EU® Coordination Centre in 2022, a service provided by Erasmus University Medical Centre Rotterdam, ten data (10) partners from seven (7) EU Member State were successfully onboarded in 2022. This granted DARWIN EU® access to over 26 million active patients in the European Union (EU).

In the second year of the establishment, DARWIN EU® will onboard additional ten (10) data partners, eight (8) of which are in the final stages of onboarding. This significant increase in capacity adds millions more active patients to the network, with additional data from five (5) more Member States being integrated. The list of newly onboarded data partners will be published on the DARWIN EU® website in due course.

EMA is continuously looking for new data partners to collaborate with DARWIN EU®. If your public or private organisation has access to real-world healthcare data, you might be interested in becoming a new data partner in DARWIN EU®. More information can be found on the DARWIN EU®  website.

Currently, eighteen (18) DARWIN EU® studies are ongoing or completed. Most of these studies are conducted on behalf of EMA’s scientific committees as well as broader collaborations with Health Technology Assessments bodies (HTAs), Payers, the European Commission or the European Center for Disease Prevention and Control (ECDC). The latter includes the EMA-ECDC collaboration through the Vaccine monitoring platform.

Study reports are published on the EU PAS register once their assessment has been completed. Some of the most recently completed studies include: 

  • Drug utilisation study (DARWIN EU®) investigating treatment patterns of drugs used in adult and paediatric population with systemic lupus erythematosus (EUPAS106436)
  • Cohort study (DARWIN EU®) aiming at understanding the utilisation pattern of endothelin receptor antagonists (ERAs) and phosphodiesterase-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH) (EUPAS106052)
  • Drug utilisation study (DARWIN EU®) investigating the annual incidence and annual period prevalence of use of opioids, in 7 European countries, and determining duration of opioid use, characteristics of new users and indication for prescribing/dispensing (EUPAS105641)
  • Drug utilisation study (DARWIN EU®) addressing Take-Home Naloxone (THN) use to treat opioid overdose (EUPAS105644)
  • Cohort study (DARWIN EU®) evaluating multiple myeloma patients’ characterisation, treatments, and survival in the period 2012-2022 (EUPAS105033)
  • Cohort study (DARWIN EU®) estimating background rates of serious adverse events and causes of death in severe asthma (EUPAS103936)
  • Natural history study (DARWIN EU®) of dermatomyositis (DM) and polymyositis (PM) in adults and paediatric populations (EUPAS107454)
  • Drug utilisation study (DARWIN EU®) of medicines with prokinetic properties in children and adults diagnosed with gastroparesis (EUPAS106798)

 Throughout 2024, DARWIN EU® will continue its collaboration with stakeholders and is working on further use case pilots with ECDC, HTAs and Payers.