In May 2025, the EMA (European Medicines Agency) and the HMA (Heads of Medicines Agencies) network took a significant step forward with the publication of the Workplan 2025-2028 by the Network Data Steering Group (NDSG). This plan builds on the Reflection Paper on AI in the drug lifecycle, adopted at the end of 2024.
Artificial Intelligence (AI) is increasingly recognized as a key driver for leveraging large volumes of regulatory and health data, as well as for developing new decision-support tools.
Key Highlights:
The EMA’s Reflection Paper established fundamental principles for the responsible use of AI across all phases of the medicine lifecycle - development, authorization, pharmacovigilance, and more. It emphasizes:
- Governance
- Transparency
- Robustness
- Risk management
- Regulatory compliance (notably the GDPR and current pharmaceutical legislation)
It also underscores the importance of proactively preparing for the European AI Act and ensuring the safety of AI systems.
The NDSG Workplan 2025-2028 translates these principles into tangible actions:
- Deployment of AI tools: for clinical data analysis and pharmacovigilance, including new capabilities for safety signal detection, SUSAR (Suspected Unexpected Serious Adverse Reactions) screening, and an enriched public site for ADR reports, scheduled for 2027.
- Harmonization and terminology: publication in 2025 of responsible AI principles and a European glossary, with the aim of international harmonization.
- Leadership and support: creation of an industry-focused AI working group, backing scientific advice procedures, developing practical guides, and organizing multi-stakeholder workshops throughout the plan.
- Regulatory alignment: integration of the requirements from the new AI Act, the European Health Data Space (EHDS), and ongoing updates to European pharmaceutical law.
Four Strategic Priorities for 2025-2028:
- Guidance, policies, and product support - advising on AI integration throughout the entire medicine lifecycle.
- Tools and technologies - developing frameworks for the safe and effective use of AI.
- Collaboration and change management - building capacity among stakeholders and raising awareness among regulators about AI transformation.
- Experimentation - adopting a structured, coordinated approach to testing and validating innovations.
Key Milestones:
- Q2 2025: Publication of the AI tools framework
- Q3 2025: Change management strategy for the European Medicines Regulatory Network (EMRN)
- Q4 2026: New pharmacovigilance signal detection capabilities
- Q1 2027: New SUSAR screening capacities
- Q4 2027: Launch of the enriched public ADR website
- 2026-2028: Workshops, reports, and phased deployment of AI tools
For industry stakeholders:
EMA and NDSG are calling on companies to proactively prepare for these developments, participate in consultations, and integrate AI into their development, compliance, and pharmacovigilance strategies.
Europe is positioning itself as a leader in responsible and ethical health AI regulation - transforming data and technological innovation into tangible benefits for public health, while ensuring trust and safety.
Links: