EU regulators update workplan for leveraging AI and big data
The European Medicines Agency’s (EMA) Network Data Steering Group (NDSG) on Monday released a joint workplan outlining a strategy for leveraging artificial intelligence (AI) and big data over the next two years to expedite the approval of new medicines.The NDSG was established in 2025 and combines the former Big Data Steering Group (BDSG) and Network Data Board (NDB) into a single governing body, co-chaired by EMA and the Heads of Medicines Agencies (HMA). Its mission is threefold: to maximize data interoperability and exchange, to enhance access to data and facilitate evidence generation, and to leverage AI for the benefit of public and animal health within the EU.
The NDSG approved the work plan in February 2026, and it will be updated annually based on feedback from stakeholders and EU network experts. This document has some minor changes from a previous version issued in March 2025 in terms of priorities, deliverables and timelines. (RELATED: EU regulators issue workplan for optimizing AI and big data, Regulatory Focus 7 May 2025)
The NDSG workplan focuses on six areas: strategy and governance, data analytics, AI, data interoperability, stakeholder engagement and change management, and guidance and international initiatives.
Under governance, the workplan states that the NDSG will contribute to the implementation of the revised pharmaceutical legislation for Europe. The group may also provide advice on real-world data (RWD), clinical study data, the revision of Annex 1, environmental risk assessments, OneHealth, and electronic product information (ePI).
As for AI, the workplan states that “AI literacy remains a critical priority (and a legal obligation under the AI Act). Therefore, the EU-Network Training Centre will roll out AI literacy initiatives across the European Medicines Regulatory Network (EMRN) while expanding and delivering training on AI. Opening the training to external stakeholders will be explored.” The network plans to launch AI literacy training for EMRN in the first quarter of 2026.
For data analytics, the workplan notes that the Data Analysis and Real-World Interrogation Network (DARWIN EU) is now fully operational and “routinely supports the evaluation work of EMA's scientific committees.” In addition, its “learnings and experiences are shared regularly with stakeholders and the EMRN.” The workplan further notes that DARWIN EU 2 will be launched in 2027, which will be an extension of DARWIN EU.
The workplan also notes that the network plans to work with the International Council on Harmonisation (ICH) to implement guidelines regarding RWD, clinical trial study protocols, Structured Product Quality submissions, model-informed drug development (MIDD), and pediatric extrapolation.
The network plans to contribute to the ICH E23 guideline RWE terminologies, metadata, and assessment principles, and develop training material for ICH M14 guideline on the use of pharmacoepidemiological studies that use RWD for assessing medicine safety.
Workplan
