人工智能在医药产业及药品监管中的应用与思考  

Application of Artificial Intelligence in Pharmaceutical Industry and Considerations for Drug Regulation

作　　者：熊玮仪 鲁爽[1] 王涛[1] XIONG Wei-yi;LU Shuang;WANG Tao(Center for Drug Evaluation,NMPA)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2024年第5期26-33,共8页China Food & Drug Administration Magazine

摘　　要：人工智能在医药产业中的应用已日益普及和深化,许多国家和地区药品监管机构均面临如何在监管活动中使用人工智能技术以及如何监管人工智能产品的双重挑战。本文概述了人工智能在医药产业中的应用现况,总结了美国食品药品监督管理局的有关实践,为在我国药品监管中合理使用人工智能提出了建议。As the application of artificial intelligence(AI)in pharmaceutical industry becomes increasingly widespread and deepens,drug regulatory authorities around the world are facing dual challenges:how to use AI technologies in regulatory activities and how to regulate AI products.This article briefly summarizes the current status of AI applications in the medical and pharmaceutical industries,and summarizes relevant practices of the U.S.Food and Drug Administration,providing suggestions for the reasonable use of AI in drug regulation in China.

关 键 词：人工智能 机器学习 药品研发 药品监管 医药产业 

分 类 号：R95[医药卫生—药学]