全球药品监管机构药品AI应用监管法规框架  

Regulatory Frameworks for Pharmaceutical AI Applications from Global Drug Regulatory Agencies

作　　者：骆实 曹凤朝 韩亮 LUO Shi;CAO Fengchao;HAN Liang(Beijing Shangzhi Hegui Science and Technology Co.,Ltd.,Beijing 100101,China)

机构地区：[1]北京尚质合规科技有限公司,北京100101

出　　处：《中国医药导刊》2025年第2期109-116,共8页Chinese Journal of Medicinal Guide

摘　　要：随着人工智能(AI)技术的发展,AI赋能制药行业已成为全球药品监管机构关注的焦点。AI技术在药物发现、非临床研究、临床试验以及上市后监管等多个环节已展现出潜力,同时也带来前所未有的监管挑战。目前,AI技术已广泛应用于药品生命周期管理及药品监管过程,广泛涉及药品安全性、有效性和质量可控性。AI的创新应用和适度监管是确保公众健康和药品质量的关键。本研究在梳理AI技术发展历程的基础上,主要基于我国国家药品监督管理局(NMPA)、美国食品药品管理局(FDA)、欧洲药品管理局(EMA)、国际人用药品注册技术协调会(ICH)、世界卫生组织(WHO)、国际药品检查合作计划(PIC/S)等关于药品监管相关文件,以及如欧盟《人工智能法案》、我国《生成式人工智能服务管理暂行办法》等有关文件,结合药品监管实际以及法律法规相关要求,充分考量政策法规、规章制度、指南共识等层面,系统性综述全球主要药品监管机构对药品生命周期中AI应用的监管框架与做法,包括基于风险的分类与分级、基于设计的监管策略、AI输出内容的标识、适用于AI的验证流程、持续性监管以及确立人类监督责任制,旨在为我国产业发展和药品监管提供理论借鉴。With the development of artificial intelligence(AI)technology,AI application in pharmaceutical industry has become the focus of global drug regulatory agencies.AI technology has demonstrated its potential in drug discovery,laboratory researches,clinical trials,and post-market surveillance,while also creating regulatory challenges.At present,AI technology has been widely used in drug life cycle management and drug regulatory processes,covering drug safety,efficacy,and quality controllability.The innovative applica-tion and appropriate regulation of AI is key to ensure public health and the quality of medicines.On the basis of sorting out the develop-ment history of AI technology,it is mainly based on relevant regulatory documents of National Medical Products Administration(NMPA)in China,the United States Food and Drug Administration(FDA),the European Medicines Agency(EMA),the International Council for Harmonization of Technical Requirements for pharmaceuticals for Human Use(ICH),the World Health Organization(WHO),The Pharmaceutical Inspection Co-operation Scheme(PIC/S)and other relevant documents on drug supervision,as well as relevant docu-ments such as the European Union's Artificial Intelligence Act,Interim Measures for the Administration of Generative AI Services in China,etc,and combined with the actual situation of drug supervision and the relevant requirements of laws and regulations,and fully considering relevant policies,regulations,rules and regulations,guidelines,consensus,this study systematically reviews the regulatory framework and practices of AI application in the drug life cycle of major drug regulatory agencies around the world,including risk-based classification and grading,design-based regulatory strategies,identification of AI output content,verification processes applicable to AI,continuous supervision,and the establishment of human supervision accountability,to provide theoretical reference for industrial development and drug regulation in China.

关 键 词：药品监管 药品生命周期 人工智能 机器学习 大语言模型 

分 类 号：R95[医药卫生—药学]