From Principles to Practice: Operationalizing the Food and Drug Administration and European Medicines Agency Guiding Principles for Artificial Intelligence in Oncology Drug Development

Artificial intelligence (AI) is transforming every stage of oncology drug development, offering unprecedented opportunities for innovation, efficiency, and patient-centered care. In January 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly published the “Guiding Principles of Good AI Practice in Drug Development” (“FDA-EMA Guiding Principles”). 1 These 10 principles establish a shared transatlantic framework for the responsible design, validation, and oversight of AI systems across the drug lifecycle. This article distills the regulatory intent behind the FDA–EMA Guiding Principles and translates them into operational guidance for oncology researchers, clinicians, and institutional leaders engaged in evidence generation.