中国食品药品监管Issue(2)：4-21,18.DOI:10.3969/j.issn.1673-5390.2025.02.001
人工智能(AI)监管与应用的全球发展趋势及思考
Global Trends and Considerations in the Regulation and Application of Artificial Intelligence(AI)
赵岩松 1张永妍 2陈健 3忻之铖 4邵瑞莹 5代蕾 5赵忠斌 6李流兵 7张伟8
作者信息
- 1. 诺华(中国)生物医学研究有限公司
- 2. 罗氏(中国)投资有限公司
- 3. 赛诺菲(中国)投资有限公司
- 4. 卫材(中国)药业有限公司
- 5. 武田亚太生物医药研发有限公司
- 6. 安进生物医药(上海)有限公司
- 7. 阿斯利康全球研发(中国)有限公司
- 8. 中国药品监督管理研究会
- 折叠
摘要
Abstract
With the rise and advancement of artificial intelligence(AI)technology,regulatory agencies and international organizations from various countries and regions have actively involved in developing relevant regulations and policies.This paper mainly introduces the AI legislative and regulatory frameworks,as well as their applications in healthcare regulation in the United States,the European Union,the United Kingdom,Japan,and China,and reviews the progress of cooperation between international organizations and regulatory agencies in the AI field.In the wave of AI development,China is also actively exploring its application scenarios in the medical and healthcare areas and has released multiple policy documents—such as the List of Typical Application Scenarios of Artificial Intelligence in Drug Regulation—to promote the healthy development and standardized application of AI.China can further engage in exchanges and cooperation with other regulatory agencies,share its experiences,actively explore its own AI regulatory model,aim to maintain a leading position in the AI field,and work to secure a stronger voice in AI regulation globally.关键词
人工智能/监管框架/药品监管/应用实践/法规政策Key words
artificial intelligence/regulatory framework/pharmaceutical regulation/application practice/regulatory policies分类
药学引用本文复制引用
赵岩松,张永妍,陈健,忻之铖,邵瑞莹,代蕾,赵忠斌,李流兵,张伟..人工智能(AI)监管与应用的全球发展趋势及思考[J].中国食品药品监管,2025,(2):4-21,18.
