January 14, 2026
Dear International Colleague,
Today, after several months of collaboration, the FDA and European Medicines Agency (EMA) are releasing a common set of 10 guiding principles to inform, enhance, and promote the use of artificial intelligence (AI) for generating evidence across all phases of the drug product life cycle.
The integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving health care. AI technologies are anticipated to help promote innovation, reduce time-to-market, strengthen regulatory excellence and pharmacovigilance, and decrease reliance on animal testing by improving the prediction of toxicity and efficacy in humans.
These 10 guiding principles lay the foundation for developing good practice that addresses the unique nature of these technologies and identifies areas for potential collaboration by international regulators, international standards organizations, and other collaborative bodies.
An unofficial translation of this announcement is provided below.
翻译参考：
FDA与EMA 发布药品开发中人工智能良好实践指导原则
2026年1月14日
尊敬的国际同仁：
经过数月的合作，美国食品药品管理局（FDA）与欧洲药品管理局（EMA）今日联合发布了一套10项指导原则，旨在指导、加强和促进人工智能（AI）在药物产品全生命周期各个阶段生成证据方面的应用。
人工智能在药品开发中的应用有望改变药物研发和评估方式，最终改善医疗健康水平。预计AI技术将有助于促进创新、缩短上市时间、加强监管水平与药物警戒能力，并通过提高对人体毒性和有效性的预测能力，减少对动物试验的依赖。
这10项指导原则为制定良好实践奠定了基础，既应对了此类技术的独特性质，也明确了国际监管机构、国际标准组织以及其他协作机构之间潜在的合作领域。
Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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