Data Analysis and Real World Interrogation Network (DARWIN EU)

(content adapted from EMA website [1])

	Further adaptation of the EU regulatory environment concerning the inclusion of Big Data obtained from RWD/RWE in regulatory procedures is ongoing. The HMA/EMA Big Data Task Force originally recommended developing ‘DARWIN EU’ (accd. to the EMA-HMA Big Data Steering Group workplan and the EMA network strategy to 2025 [2]).

EMA is establishing a coordination centre (DARWIN EU^®) the Data Analysis and Real- World Interrogation Network that will:

Provide 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).
Deliver real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.
Enable EMA and national competent authorities in the the European medicines regulatory network to use these data whenever needed throughout the lifecycle of a medicinal product.
Support 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.

Connect the European medicines regulatory network to the European Commission's European Health Data Space (EHDS),
Contribute to developing the EHDS to deliver European principles for the secondary use of health data, known as Towards European Health Data Space (TEHDAS).
Act as an early flagship 'pathfinder' for the EHDS, to enable the exchange of healthcare data for use in healthcare delivery, policy-making and research across Europe, while fully complying with data protection requirements.

References

2. Data Analysis and Real World Interrogation Network (DARWIN EU)