Data Analysis and Real World Interrogation Network (DARWIN EU)

(content adapted from EMA website [1])

Darwin EU

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:

    • 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.


[1] EMA ‘Data Analysis and Real-World Interrogation Network (DARWIN EU)’.
[2] Big Data Steering Group Big Data Workplan 2022-2025.