EU regulators issue workplan for optimizing AI and big data

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on Wednesday released a joint work plan detailing their strategy for optimizing the use of artificial intelligence and big data over the next five years. This plan focuses on utilizing large volumes of regulatory and health data, along with AI, to enhance the regulatory decision-making process for approving new medicines.

The workplan lays out a framework for managing and sharing data across the network, while adhering to “high security and ethical standards,” EMA said. It also addresses how to coordinate new legislative initiatives, such as the pharmaceutical legislation, the European Health Data Space (EHDS), the Interoperable Europe Act and the EU AI Act.

The work plan was adopted by the joint HMA/EMA Network Data Steering Group (NDSG) in March 2025. It will be updated annually based on feedback from stakeholders and EU network experts. The NDSG, which combines the Big Data Steering Group and the Network Data Board, will oversee the implementation of the work plan. The plan replaces an earlier version issued in 2023. (RELATED: EU agencies adopt workplan on AI in medicines regulation, Regulatory Focus 18 December 2023)

EMA officials announced the release of the work plan during the DIA Europe meeting in Basel, Switzerland last March. (RELATED: DIA Europe: EMA to release new AI work plan, Regulatory Focus 26 March 2025).

According to an announcement, “the workplan translates the objectives of the European medicines agencies network strategy to 2028 into concrete deliverables. These include strengthening the network’s data analytics capabilities to generate high-quality evidence using both established and novel methods.”

The NDSG workplan addresses six workstreams: strategy and governance, data analytics, AI, data interoperability, stakeholder engagement and change management, and guidance and international initiatives.

In the strategy area, the plan said that work will be ongoing to “ensure the EMRN [European Medicines Regulatory Network] data assets meet high quality standards, are appropriately managed, standardised and easy to share.” Plans are to finalize the EMRN strategy in the third quarter of 2025.

In the field of data analytics, regulators have stated that NDSG will evaluate advanced and innovative methodologies. This includes biostatistics, signal detection, modeling and simulation data, artificial intelligence (AI), and pharmacoepidemiology. NDSG will also review data types that can complement clinical data such as genomic data, synthetic data, digital twin data, and patient experience data (PED).

From 2025 to 2027, NDSG will review these different methodologies and data types and discuss the current progress, opportunities, challenges and applications of such methods and data types for generating evidence for regulatory decision-making. “Ultimately NDSG will be able to agree on common network positions and actions that the group will take and/or sponsor to enable the use of such methods and data types.”

The workplan further states that in the data analytics area, the Data Analysis and Real-World Interrogation Network (DARWIN EU), the federated network to enable access and analysis of real-world data (RWD) is “now fully operational and routinely supports the evaluation work of EMA's scientific committees.”

In the governance area, the work plan outlines that “key European Union legislative initiatives and regulations will be implemented in the coming years.” To prepare stakeholders and the Network for these changes, the NDSG will support the implementation of the new pharmaceutical legislation for Europe, the European Health Data Space (EHDS), and the health data quality label project, QUANTUM.

Workplan

EU regulators issue workplan for optimizing AI and big data

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