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US, European Regulators Set Principles for 'Good AI Practice' in Drug ...
The FDA and European Medicines Agency established 10 principles focusing on oversight, risk management, and transparency to maintain safety as AI use in drug development grows.
- The FDA and the European Medicines Agency issued ten guiding principles for drug manufacturers on Wednesday, offering broad guidance on AI use throughout a medicine's lifecycle.
- Amid rising AI adoption in drug R&D, regulators moved to maintain current safety and efficacy standards while aiming to speed drug discovery and reduce animal testing.
- Requiring risk-based validation and human-AI testing, the principles mandate human-centric design, plain-language disclosure for users and patients, and stress data governance with multidisciplinary experts and model developers.
- According to the agencies, the list will underpin future U.S. and EU guidance and support international standards bodies, while regulatory submissions involving AI will require stronger multidisciplinary integration and documented data provenance.
- Recent deal-making shows rapid AI adoption in drug R&D, with biopharma partnerships accelerating while the FDA uses its generative AI tool Elsa following the 2024 FDA-EU bilateral meeting.
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15 Articles
EU And US Regulators Reach Landmark Accord On AI Principles In Drug Development
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly established new AI principles in drug development to reduce regulatory divergence between the major markets of the European Union and the United States. Industry associations have applauded the landmark accord, as it strengthens harmonisation across the regions – but emphasise […]
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