DARWIN EU®: a transformation in the use of real-world health data for regulatory purpose in the EU

Norway is home to some of the world’s most comprehensive and well-maintained health care registries, containing rich data on patient demographics, diagnoses, treatments, and outcomes.

University of Oslo, PharmaSafe research group is one of two Norwegian Data Partner in the DARWIN EU® project. The role of UiO researchers is to contribute with expertise and Norwegian healthcare data in Darwin studies.

Contact

 

We contribute with two data sets:

Norwegian linked health registries: NLHR@UiO. 5,5 M individuals

NLHR has full coverage of both primary and secondary care for an entire nation with the high-quality birth registry.

Norwegian linked health registries: NLHR@UiO: Perinatal: 1,94 M pregnancies (mother, father, child)

What is DARWIN EU® ?

The European Medicines Agency (EMA) and the European Medicines Regulatory Network have created a network for evidence generation regarding the use, safety, and efficacy of medicines and vaccines for human use, utilizing real-world healthcare databases in Europe. This initiative is known as the Data Analysis and Real World Interrogation Network (DARWIN EU®).   

What do we contribute with?

Factsheet
RegionNorway (nationwide)
Number of patients5.7 Mill
Coverage100%
Period covered

Core: 2018-2023

 

Primary care/ pregnancies: 2008-2023

Setting of carePrimary and Secondary care
Which data is coveredNational registries
Darwin EU DP since2024

 

The following nation-wide registries are linked at an individual patient level in NLHR:

Norwegian Prescription Database (LMR): Records all outpatient dispensed drugs. Norwegian Immunization Registry (SYSVAK): Tracks all vaccination details. Norwegian Surveillance System for Communicable Diseases (MSIS): Records notifiable infectious diseases. Norwegian Patient Registry (NPR): Records hospital diagnoses and treatments. Norwegian Registry for Primary Health Care (KPR/KUHR): Records diagnostic codes from primary care. The Medical Birth Registry of Norway (MBRN): Collects data on all pregnancies with gestational week over 12, including adverse pregnancy outcomes. Statistics Norway (SSB): Provides data on family structure and socio-demographics. Cause of Death Registry (DR): Contains mortality data for survival analysis.

We have mapped our data onto the OMOP Common Data Model, and describe the process here:

Harmonizing Norwegian registries onto OMOP common data model: Mapping challenges and opportunities for pregnancy and COVID-19 research. Trinh NT, Houghtaling J, Bernal FL, Hayati S, Maglanoc LA, Lupattelli A, Halvorsen L, Nordeng HM. Int J Med Inform. 2024 Nov;191:105602.

OMOP Mapping Journey

Current status: OMOP CDM is generated over PostgreSQL DBMS. NHLR CDM has been initially released in 2024. A new CDM released with data up to 2024-06-01 and revised and validated versions in two other versions. Revisions made to enhance drug mappings and observation periods.

Challenges:

  1. Launching database in an isolated secure space in UiO.
  2. Mapping local codes to standard OMOP concepts, including procedures and drugs.
  3. Drug mapping needs continuous updates to include new product codes.
  4. Any change to each CDM table should be followed by re-validation of the whole CDM.

Participants

Funding

Darwin is supported by the European Medicines Agency (EMA), leveraging resources and expertise from various stakeholders to build a robust network for real-world data analysis.

Collaborators

The Darwin project is a collaborative endeavor involving 30 partners in 16 European countries, covering 180 million individuals. Average study time after protocol approval: 4 months.

Map of Europe with the following countries marked in a darker colour: Portual, Spain, France, Belgium, The Netherlands, Germany, U.K., Italy, Greece, Hungary, Croatia, Estonia, Finland, Sweden, Denmark, Norway.
Photo: mapchart.net

For more detailed information about the Darwin project and its scope, visit the official Darwin website.

Published Dec. 4, 2025 8:46 AM - Last modified Dec. 4, 2025 9:52 AM