The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly released ten guiding principles for good artificial intelligence (AI) practice in the medicines lifecycle, marking a major step toward international collaboration in medical innovation.

 

The principles provide broad guidance for AI use in evidence generation and monitoring across all stages of a medicine’s life, from early research and clinical trials to manufacturing and safety surveillance. They are relevant for medicine developers, marketing authorisation applicants, and holders, and will underpin future AI guidance across jurisdictions. 

 

“The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation in the field of novel medical technologies. The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our leading role in the global innovation race, while ensuring the highest level of patient safety,” said European Commissioner for Health and Animal Welfare, Olivér Várhelyi.

 

AI use in the medicines lifecycle has surged in recent years. As highlighted in the European Commission’s Biotech Act proposal, AI promises to accelerate the journey from innovation to safe, effective medicines. The new pharmaceutical legislation expands AI’s role in regulatory decision-making and opens opportunities to test innovative AI-driven methods in controlled environments.

 

Experts caution that realizing AI’s potential requires careful management and risk mitigation. The principles-based approach is designed to help regulators, pharmaceutical companies, and medicine developers harness AI while safeguarding patient and animal safety and regulatory compliance. Over time, additional EU guidance will complement the principles, reflecting legal requirements and emerging legislation in the pharmaceutical sector.