EMA and FDA Align on Good AI Practice in Drug Development
EMA and FDA have jointly issued guiding principles for the safe and responsible use of AI across the medicines life cycle, aiming to harmonize the path for drug developers using AI-driven programs to advance innovation that benefits patients.
On January 14, 2026, the European Medicines Agency ("EMA") and the U.S. Food and Drug Administration ("FDA") published a joint set of Guiding Principles of Good AI Practice in Drug Development (the "Principles"), setting out a shared regulatory vision for the use of artificial intelligence ("AI") across the full medicines life cycle. The collaborative EMA-FDA initiative aims to maximize AI's potential for accelerating the path from innovation to safe and effective medicines while safeguarding patients and maintaining reliable data and regulatory standards.
The Principles provide high-level guidance for drug developers, marketing authorization applicants, and holders on how AI should be used to generate and monitor evidence across all stages of the medicines life cycle, from early research and clinical development to manufacturing and post-marketing safety activities. The Principles are intended to inform future regulatory policies and guidance across jurisdictions and to underpin enhanced international cooperation on AI in drug development.
While the Principles are broad in scope, they are centered around core concepts that allow for flexibility across different AI use cases to support innovation. Among other things, the Principles emphasize alignment with ethical and human-centric values, adherence to relevant drug development standards, a risk-based approach, clear context of use, robust data governance, multidisciplinary expertise, life cycle management, and the need for clear and accessible communication about AI systems. By way of illustration, the Principles could be applied to AI-enabled clinical trial design and patient recruitment, machine-learning-driven pharmacovigilance and signal detection, analysis of real-world evidence to support regulatory and post-authorization decision-making, and predictive AI tools for manufacturing process control and quality assurance.
The joint publication represents a concrete outcome of renewed EU-U.S. cooperation on emerging health technologies. By articulating a common set of expectations at an early stage, EMA and FDA aim to promote international harmonization, support innovation, and reduce regulatory fragmentation. Companies using or planning to use AI in this context should assess their current practices against the Principles. While adoption of the Principles is currently voluntary, early alignment with the Principles could become a strategic advantage, shaping what becomes the standard or recommended in future regulatory guidance on both sides of the Atlantic.
