人工智能在我国上市后药物警戒中的应用现状分析和启示  

Analysis of the Current Application Status and Enlightenment of Artificial Intelligence in Post-marketing Pharmacovigilance in China

作　　者：王涛 张琳[2] 王青[2] 柳鹏程[3] 沈传勇 WANG Tao;ZHANG Lin;WANG Qing;LIU Pengcheng;SHEN Chuanyong(Center for Drug Reevaluation of the National Medical Products Administration,Key Laboratory for Research and Evaluation of Pharmacovigilance,National Medical Products Administration,Beijing 100022,China;Pharmacovigilance Information Technology and Data Science Innovation Center of Tsinghua University,Beijing 100084,China;Institute of Regulatory Science for Medical Products,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100022 [2]清华大学药物警戒信息技术与数据科学创新中心,北京100084 [3]中国药科大学药品监管科学研究院,南京211198

出　　处：《医药导报》2025年第4期560-564,共5页Herald of Medicine

基　　金：国家自然科学基金面上项目(72274065);药品监管科学全国重点实验室课题(2024SKLDRS0233);国家药品监督管理局药品监管科学体系建设重点项目(RS2024G001)。

摘　　要：药物警戒作为药品上市后监管的重要组成部分,对于保障公众用药安全至关重要。近年来,人工智能(AI)技术凭借其强大的数据处理和分析能力,在药物警戒领域展现出巨大的应用潜力。该文从药品上市后监管视角,系统介绍和分析了AI在药物警戒中的应用背景、在中国和国外上市后药物警戒中的探索应用现状,重点阐述了AI在中国的应用案例,以及伴随的问题和挑战等,以期为我国的药品上市后监管工作提供借鉴。目前,中国AI技术在药物警戒中的探索和应用刚刚起步,应该加大力度、加快速度。监管机构应积极制定并执行AI新技术在产品全生命周期的监管标准或相关指南,加强相关人员培训和人才培养与引进,积极推动监管机构、制药企业、科研院所及高校等开展紧密合作,共同推动AI技术在药物警戒领域的创新应用。Objective Pharmacovigilance,as an essential component of post-marketing drug regulation,plays a crucial role in ensuring the safety of public medication use.In recent years,Artificial intelligence(AI)technology,with its powerful data processing and analysis capabilities,has shown tremendous potential in the field of Pharmacovigilance.This article introduced and analyzed the application background of AI technology in Pharmacovigilance,its exploration and current status both internationally and within China,highlighted its application in the country,as well as the associated problems and challenges from the perspective of post-marketing regulation.It aims to provide reference for post-marketing regulation in China.Currently,China's exploration and application of AI in pharmacovigilance have just begun,and efforts should be intensified and the pace accelerated.Regulatory agencies should actively develop and implement regulatory standards or relevant guidelines for AI technologies throughout the product lifecycle,strengthen personnel training,talent cultivation,and introduction,actively promote close cooperation among regulatory agencies,pharmaceutical companies,research institutes,and universities,and jointly promote the innovative application of AI technology in the field of drug regulation.

关 键 词：人工智能 机器学习 药物警戒 个例安全性报告 上市后监管 

分 类 号：R96[医药卫生—药理学]