中国食品药品监管Issue(4)：4-15,12.DOI:10.3969/j.issn.1673-5390.2026.04.001
人工智能在药品监管应用中的法律挑战探讨
Legal Challenges of Artificial Intelligence in Drug Regulation
摘要
Abstract
This study examines the legal issues arising from the application of artificial intelligence(AI)in drug regulation.Through a systematic review of regulatory developments in major jurisdictions,including the European Union,the United States,the United Kingdom,and Japan,it analyzes key institutional progress across the following dimensions:data security,regulatory liability,data governance boundaries,privacy protection,intellectual property,and trade secrets.The study further explores the new requirements imposed on regulatory rules and governance mechanisms following the integration of AI into drug regulatory processes.Based on a comparative analysis of institutional arrangements and practical approaches across jurisdictions,it identifies a growing convergence in key areas,including high-risk governance,data governance,human oversight,lifecycle management,and transparency obligations.On this basis,the paper discusses implications for the development of China's regulatory framework for AI in drug regulation,aiming to provide policy insights for balancing technological innovation,regulatory effectiveness,and public safety.关键词
人工智能/药品监管/数据安全/监管责任Key words
artificial intelligence/drug regulation/data security/regulatory liability分类
社会科学引用本文复制引用
王翔宇,侯艳,杨蕾,王海南,袁林..人工智能在药品监管应用中的法律挑战探讨[J].中国食品药品监管,2026,(4):4-15,12.基金项目
中国食品药品国际交流中心项目 （）
