What will DARWIN EU deliver?
This enables EMA and national competent authorities in the European medicines regulatory network to use these data whenever needed throughout the lifecycle of a medicinal product.
DARWIN EU supports 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.
The former HMA/EMA Big Data Task Force originally recommended developing DARWIN EU. The creation of DARWIN EU features in the EMA-HMA Big Data Steering Group workplan and the European medicines agencies network strategy to 2025.
For more information:
In February 2022, EMA selected a service provider (Erasmus University Medical Center Rotterdam) to deliver DARWIN EU, following a call for tender.
In 2022 and 2023, the service provider will:
- set up DARWIN EU's operational processes and governance structures;
- run studies with data from DARWIN EU, to support EMA scientific committees and down-stream decision-makers in their decision-making and support the establishment of the EHDS.
In 2024, EMA expects DARWIN EU to be fully operational. At this stage, DARWIN EU will routinely support the evaluation work of EMA's scientific committees and the national competent authorities.
Organisations such as the European Centre for Disease Prevention and Control, Health technology assessment bodies and payers may make use of DARWIN EU in the longer term.
Figure 1: Overview of DARWIN EU timelines
Select service provider to deliver the DARWIN EU Coordination Centre
Establish DARWIN EU Advisory Board
Support EDHS pilot
DARWIN EU establishment
Define governance structures, contract models and processes
Run early studies to support EMA committees
Provide first catalogue of real world data sources and standard analyses
Establish connectivity with EHDS
Developing and using DARWIN EU
Launch publicly-available DARWIN EU website
Work with established data permit authorities
Test business process to access and analyse healthcare data
Run studies to support more EMA committees
Full operation mode
Conduct studies and answer questions to support EMA scientific committees and national competent authorities
DARWIN EU fully operational with involvement of data partners and medicine regulators
Leverage the EU Health Data Space
Increase geographical coverage, scope and regulatory uses of healthcare data in DARWIN EU