DARWIN EU delivers real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.
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.
DARWIN EU provides timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU).