Summary
Joint EMA-FDA principles describing how artificial intelligence and machine learning can be responsibly integrated across the lifecycle of medicinal product development, including discovery, trial design, data management, analysis, and post-authorization activities.
Healthcare Implications
Signals regulators’ expectations for safe, transparent, and robust use of AI in drug development workflows; encourages sponsors to build governance, validation, and monitoring processes that protect patients, improve evidence quality, and reduce bias in AI-enabled trials and decision making.