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FDA and EMA issue ten joint principles for AI in drug development

PolicyHealthScienceUS EU INTLConfirmed

FDA's drug and biologics centres and the European Medicines Agency published ten shared 'Guiding Principles of Good AI Practice in Drug Development'. They cover the whole medicine lifecycle, asking for a risk-based approach tied to a defined context of use, data governance, documentation, multidisciplinary development, lifecycle performance monitoring and plain-language communication.

Why it matters

Sponsors using AI in trials, manufacturing or safety monitoring get a single transatlantic baseline, reducing divergent expectations between the two largest drug regulators.

SourceU.S. Food and Drug AdministrationCoverage: RAPS Checked against the primary source. Independently fact-checked on 7 Oct 2026.
FDAEuropean Medicines Agency

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Threads by topic: Drug discovery Standards and codes International cooperation