HMA/EMA Joint Network Data Steering Group (NDSG)
Introduction/Overview/Mandate
The joint HMA-EMA Network Data Steering Group (NDSG) is a strategic advisory group, established to enhance data use in medicine regulation and decision-making, supporting innovation and public health in the EU. Its goals include improving data interoperability, exchange, and use of data within the regulatory network, enhancing access to data and evidence generation, and leveraging AI in regulatory decision-making.
The group advises HMA and EMA Management Board on the implementation of the European medicines agencies network strategy to 2028, particularly contributing to the achievement of the goals related to leveraging data, digitalisation, and artificial intelligence.
The joint HMA-EMA Network Data Steering Group supersedes the joint HMA-EMA Big Data Steering Group that operated between December 2019 and January 2025.
The previous steering group had replaced the HMA-EMA Big Data Task Force that functioned between 2017 and 2019.
Members and representatives
The NDSG members include representatives from national competent authorities, EMA and the European Commission, as well as representatives from various stakeholder groups.
The group covers a wide range of expertise in IT and data, including analysis, use and decision-making as well as data management, interoperability and standardisation.
The group is co-chaired by the HMA and EMA representatives.
Contact
EMA Secretariat: NDSG@ema.europa.eu
Key documents
- Joint HMA/EMA Network Data Steering Group Workplan 2025-2028
- For additional information and reference to key documents, please visit the webpage ‘Data in regulation: Big data and other sources | European Medicines Agency (EMA)’
- Stay up-to-date on the implementation of the Network Data Steering Group work plan with the quarterly news. Read Big Data highlights newsletter here and subscribe here.