EMA and HMA launch 2028 plan to use AI and real-world data in EU medicines regulation

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a joint workplan outlining how data and AI will be used to support faster, evidence-based decision-making across the EU regulatory network.

The five-year plan, titled, “Data and AI in medicines regulation to 2028”, details how regulators will manage, analyze, and share regulatory and health data to support research, improve interoperability, and enable more timely authorization of medicines. Developed by the joint Network Data Steering Group (NDSG), the roadmap also ensures alignment with EU legislative initiatives including the European Health Data Space (EHDS), the AI Act, and upcoming pharmaceutical reforms.

"In view of the technology-driven explosion of data, we need to be strategically aligned across the EU in terms of data governance, management and AI-powered analysis tools to transform data into tangible benefits for public and animal health,” said Peter Arlett, EMA’s Head of Data Analytics and Methods Task Force and NDSG co-chair.

The workplan is built around six core workstreams that aim to strengthen the network’s digital and analytical capacity:

1. Strategy and governance

A coordinated approach will ensure high standards in data quality, sharing, and analytics across the network. The EMRN’s data, standardization, and analytics strategies will guide the management and use of data assets to support both human and animal health. Updates to the EU veterinary big data strategy and workplan are also planned. Ongoing horizon scanning and monitoring of emerging tools will inform future priorities, with the plan reviewed annually based on stakeholder input.

2. Data interoperability

The EMRN will improve regulatory data access through better cataloguing, integration with veterinary data, and alignment with the EHDS catalogue. A data quality strategy will target key domains like RWD, adverse drug reactions, and product master data. The Product Management Service (PMS) will be the central source for product data, with pilots testing its use. The NDSG will also promote alignment with international standards, including HL7, ISO, and ICH, and support  EU-funded projects like the UNICOM2 Joint Action project to boost interoperability and evidence quality.

3. Data analytics

The Data Analysis and Real-World Interrogation Network (DARWIN EU®) will continue expanding to deliver real-world evidence across the EU network, with DARWIN EU 2 planned for 2027. New data partners will be onboarded annually, with yearly experience reports published. The Committee for Medicinal Products for Human Use (CHMP) clinical study data pilot will test the use of individual patient data to enhance regulatory decisions and guidance. The NDSG will review advanced methods, such as AI, modeling, and signal detection, and assess new data types including genomic, synthetic, and mobile health data to inform future pilots and regulatory use.

4. AI

AI will be integrated across the medicines lifecycle to improve regulatory efficiency and decision-making, while ensuring ethical, compliant use under EU rules like the AI Act and GDPR. Key milestones include:

• 2025: EMA to publish responsible AI principles, a terminology guide, and launch a network-wide change management strategy. An AI industry working group will be established, and the Digital Academy will expand with AI masterclasses.
• 2026: Start of six-month experimentation cycles to test AI methods.
• 2027: Review of experimentation outcomes.

Additional actions include launching an AI Tools framework, creating a Network AI Observatory for annual trend reports, and hosting stakeholder events like hackathons. The AI Special Interest Area will remain a key forum for expert input. The EMRN aims to harness AI responsibly to advance regulatory science while managing emerging risks.

5. Stakeholder engagement and change management

A network-wide change management strategy will be launched in 2025 to support the EMRN’s shift to data-driven regulation and build stakeholder trust. It will focus on key areas such as RWE, AI, clinical study data analysis, and PMS. Training and communication will build capacity and share best practices. The EU Network Training Centre will expand its curriculum, with ongoing reviews to address evolving needs. Engagement will include annual data forums, topic-specific workshops, and collaboration through expert groups and the Regulatory Optimisation Group, aiming to ensure informed adoption and stronger cross-sector collaboration.

6. Guidance and international initiatives

EU regulators will continue developing guidance to support evidence-based decisions. In 2025, key outputs include a reflection paper on RWE, a concept paper on good pharmacogenomic practice, and Q&As on registries and synthetic covariates. A paper on patient experience data is due in 2026. The NDSG will support guidance development and contribute to CHMP and ACT EU workplans. International alignment remains a priority, with ongoing collaboration through ICH and ICMRA. Also expected in 2025 are a concept paper on RWE terminology, finalization of ICH M14 guideline, and continued work on ICH M15. A joint RWE study on public health emergencies will also be launched under ICMRA.

"We are excited to join forces to harness data and AI to improve public health across the EU and realize the vision of the network in its strategy to 2028,” said Karl Broich, President of Germany’s BfArM and NDSG co-chair. “Through collaboration, stakeholder engagement, training and guidance, we aim to drive impactful outcomes throughout the workplan."