US, European regulators set principles for ‘good AI practice’ in drug development
The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible use of artificial intelligence in developing medicines, aiming to speed up innovation while safeguarding patients.
The principles, issued on Wednesday, offer broad guidance on how AI should be used to generate and monitor evidence across a drug’s lifecycle, from early research and clinical trials to manufacturing and safety surveillance.
The move comes as regulators push to expand the use of AI in drug discovery and development to shorten timeline and reduce animal testing.
The FDA has a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews.
European guideline work is already under way, building on the EMA’s 2024 AI reflection paper, and aligns with the agency’s mission to promote safe and responsible use of AI.
The joint initiative follows an FDA–EU bilateral meeting in 2024.
“The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation… to preserve our leading role in the global innovation race, while ensuring the highest level of patient safety,” European Commissioner for Health and Animal Welfare Oliver Varhelyi said.
Several drugmakers are increasingly relying on sophisticated AI models to design and discover new treatments and striking deals to gain the technical know-how.
Earlier this week, AstraZeneca agreed to buy Boston-based Modella AI to accelerate oncology drug research, while AI chip giant Nvidia and Eli Lilly said they would spend $1 billion building a new joint research lab in the San Francisco Bay area over five years.
