Jurisdiction(s):
European Union

FDA–EMA joint AI principles for medicines: non-binding, risk-based and life cycle-led framework signalling transatlantic alignment for biopharma R&D, trials, manufacturing and pharmacovigilance

Published on: 26 January 2026

Published by a Law360 reporter

Legal News

Article summary

The ten statements are wide-ranging and address shared priorities for regulators in the fast-moving AI arena, yet taken together they show both agencies are receptive to AI, able to collaborate, and are getting ready for its broader application in drug research, clinical trials, manufacturing and monitoring, observers said. Industry consistently seeks greater predictability, noted Elizabeth Mulkey, a partner in the technology and life sciences groups at Goodwin Procter LLP, who added that the joint publication signals that regulators globally are aiming to approach the issue in a similar way. On 14 January 2016, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) issued common principles, describing them as the bedrock for more detailed guidance that each jurisdiction will produce independently. The statements emphasise ethical use of AI, clear explanations of what the technology does and for what purpose, and regular testing to ensure a model remains accurate over time. Sarah Cowlishaw, a Covington & Burling LLP partner based in London and Dublin, called the principles welcome news for the biopharma sector...

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