中国食品药品监管Issue(3)：14-21,8.DOI:10.3969/j.issn.1673-5390.2025.03.002
欧美人工智能在制药领域应用的监管政策研究及对我国的启示
Research on the Regulatory Policies of Artificial Intelligence in the Pharmaceutical Field in Europe and the United States and Its Implications for China
摘要
Abstract
This study focuses on the regulatory policies for the application of artificial intelligence(AI)in the pharmaceutical field.By systematically reviewing the regulatory strategies and practices of pharmaceutical regulatory agencies in Europe and the United States,it analyzes how these policies balance the promotion of technological innovation with the assurance of safety.Based on the analysis of European and American regulatory policies,this paper presents preliminary thoughts on the development of regulatory policies for the application of AI in China's pharmaceutical field,aiming to contribute to the establishment of a regulatory environment that encourages innovation and ensures safety,thereby promoting the sustainable development of the AI pharmaceutical industry.关键词
人工智能/制药领域/监管政策/应用Key words
artificial intelligence/pharmaceutical field/regulatory policies/application分类
药学引用本文复制引用
谢金平,张鼎衡,陈怡,朱梦雅,黄淼,邵蓉..欧美人工智能在制药领域应用的监管政策研究及对我国的启示[J].中国食品药品监管,2025,(3):14-21,8.基金项目
中国食品药品国际交流中心委托"人工智能在制药领域应用的监管政策研究"项目 （）
