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FDA and EMA issue ten joint principles for AI in drug development
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.
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Earlier developments on the same thread
- DevelopmentFDA loosens oversight of AI decision-support software and health wearables6 Jan 2026 · Rule change · US
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- DevelopmentMIT team uses generative AI to design new antibiotics active against gonorrhoea and MRSA14 Aug 2025 · Research · US
- DevelopmentGoogle unveils Gemini-based 'AI co-scientist' with lab-validated hypotheses19 Feb 2025 · Research · US, GB
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Later developments on the same thread
- DevelopmentIndia hosts AI Impact Summit in New Delhi, first in the series in the Global South16 Feb 2026 · Statement · IN, INTL
- DevelopmentNew Delhi Declaration on AI Impact endorsed by 88 states and bodies, incl. US and China21 Feb 2026 · Statement · IN, INTL
- DevelopmentUS moves UAE into top export tier, opening licence-free AI chips to approved users10 Jul 2026 · Rule change · US, AE
- DevelopmentUN expert group agrees final report on autonomous weapons; treaty question deferred4 Sep 2026 · Statement · INTL, FR
Same story elsewhere
What other countries and bodies did on this
- DevelopmentInsilico doses first patients in Phase III trial of AI-discovered drug rentosertib10 Sep 2026 · Research · CN
- DevelopmentIsomorphic Labs raises $2.1bn for its AI drug-design engine12 May 2026 · Deal · GB
Threads by topic: Drug discovery Standards and codes International cooperation