EMA and FDA set common principles for AI in medicine development

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Source: EMA News

Original: https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-deve...

Published: Wed, 14 Jan 2026 16:18:03 +0100

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly identified ten principles of good practice for artificial intelligence (AI) in the drug lifecycle.[1] These principles guide the use of AI in evidence generation and monitoring throughout all phases of medicine, from early research and clinical trials to manufacturing and safety monitoring.[1] This is the first step of the renewed cooperation between the EU and the USA in the field of new medical technologies.[1] The principles were established as part of the work of the EMA and the FDA to promote the safe and ethical use of AI.[1][2]