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FDA and EMA Release Guiding Principles of Good AI Practice in Drug Development
January 14, 2026
Dear International Colleague,
Today, after several months of collaboration, the FDA and European Medicines Agency (EMA) are releasing a common set of 10 guiding principles to inform, enhance, and promote the use of artificial intelligence (AI) for generating evidence across all phases of the drug product life cycle.
The integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving health care. AI technologies are anticipated to help promote innovation, reduce time-to-market, strengthen regulatory excellence and pharmacovigilance, and decrease reliance on animal testing by improving the prediction of toxicity and efficacy in humans.
These 10 guiding principles lay the foundation for developing good practice that addresses the unique nature of these technologies and identifies areas for potential collaboration by international regulators, international standards organizations, and other collaborative bodies.
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