The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly identified ten principles for good practice for artificial intelligence (AI) in the life cycle of medicines. These principles provide broad guidelines for the use of AI in evidence generation and monitoring at all stages of a drug, from early research and clinical trials to manufacturing and safety monitoring. The principles emphasize a human-centered approach, a risk-based approach, adherence to standards, a clear context of use, multidisciplinary expertise, data management and documentation, model design, performance evaluation, life cycle management, and clear information. They are relevant to drug developers, applicants and marketing authorization holders and support international regulatory cooperation. The initiative builds on the FDA-EU bilateral meeting in April 2024 and EMA's EMANS strategy to 2028. The principles form the basis for future EU guidance and help harness AI to accelerate innovation while maintaining safety patients.[](https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0)[](https://www.fda.gov/about-fda/artificial-intelligence-drug-development/guiding-principles-good-ai-practice-drug-development)