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

作　　者：谢金平 张鼎衡 陈怡[1] 朱梦雅 黄淼 邵蓉[1] XIE Jin-ping;ZHANG Ding-heng;CHEN Yi;ZHU Meng-ya;HUANG Miao;SHAO Rong(Institute of Regulatory Science for Medical Products,China Pharmaceutical University;China Center for Food and Drug International Exchange)

机构地区：[1]中国药科大学药品监管科学研究院 [2]中国食品药品国际交流中心

出　　处：《中国食品药品监管》2025年第3期14-21,共8页China Food & Drug Administration Magazine

基　　金：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。

摘　　要：本文聚焦人工智能(AI)应用于制药领域的监管政策研究,通过系统梳理欧美药品监管机构的监管策略和实践,解析监管政策如何在促进技术创新与保障安全之间寻求平衡。基于对欧美AI制药监管政策的分析,本文初步提出了关于我国AI应用于制药领域监管政策的思考,旨在助力构建鼓励技术创新、保障公众安全的政策环境,引导AI制药行业的持续健康发展。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 

分 类 号：R95[医药卫生—药学]