药物临床研究阶段申办者和生产场地变更研究七:我国新药临床研究阶段申办者和生产场地及其变更的管理对策研究  

ResearchⅦon the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Research on the Management Strategies for the Sponsors and Production Sites and Their Changes during the Clinical Research Phase of New Drugs in China

作　　者：杨建红 王方敏 吴正宇 陈震[4,5] 顾瑶华 连志荣 芦臣书 于冰 夏雨 李圆圆 王宏扬 武志昂 张伟 Yang Jianhong;Wang Fangmin;Wu Zhengyu;Chen Zhen;Gu Yaohua;Lian Zhirong;Lu Chenshu;Yu Bing;Xia Yu;Li Yuanyuan;Wang Hongyang;Wu Zhiang;Zhang Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China;Shanghai Drug and Medical Device Adverse Reaction Monitoring Center,Shanghai 200040,China;Novo Nordisk(Shanghai)Pharmaceutical Trading Co.,Ltd.,Shanghai 200131,China;School of Pharmacy,Zhengzhou University,Zhengzhou 450001,China;Yeehong Business School,Shenyang Pharmaceutical University,Beijing 100055,China;Suzhou Industrial Park Drug Administration Center,Suzhou 215127,China;AstraZeneca Global Research and Development China Center,Beijing 100176,China;BeiGene(Beijing)Biotechnology Co.,Ltd.,Beijing 100022,China;China Association of Enterprises with Foreign Investment R&D-based Pharmaceutical Association Committee,Beijing 100020,China;Yangtze River Pharmaceutical Group Shanghai Hailu Biotechnology Co.,Ltd.,Shanghai 201203,China;Zai Lab(Shanghai)Co.,Ltd.,Beijing 100022,China;China Society for Drug Regulation,Beijing 100082,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076 [2]上海市药品和医疗器械不良反应监测中心,上海200040 [3]诺和诺德(上海)医药贸易有限公司,上海200131 [4]郑州大学药学院,郑州450001 [5]沈阳药科大学亦弘商学院,北京100055 [6]苏州工业园区药品管理中心,苏州215127 [7]阿斯利康全球研发中国中心,北京100176 [8]百济神州(北京)生物科技有限公司,北京100022 [9]中国外商投资企业协会药品研制和开发工作委员会,北京100020 [10]扬子江药业集团上海海路生物技术有限公司,上海201203 [11]再鼎医药(上海)有限公司,北京100022 [12]中国药品监督管理研究会,北京100082

出　　处：《中国药事》2024年第5期549-557,共9页Chinese Pharmaceutical Affairs

基　　金：中国药品监督管理研究会委托亦弘商学院开展的“我国临床研究阶段申办者和生产场地变更研究”课题(编号2021-Y-Y-22)。

摘　　要：目的:提出我国新药临床研究阶段申办者和生产场地及其变更的管理对策,为适应药品研发新形势发展和完善我国药品监管政策提供参考。方法:对当前国内临床研究阶段申办者和生产场地管理中的问题进行分析,借鉴国外监管机构的管理经验,基于风险原则进行综合评估研判,提出适合我国国情的相关管理对策。结果与结论:以确保受试者安全为核心,以鼓励创新、改善公众用药的可及性和可获得性为目标,提出关于强化申办者作为主体的责任、加强临床试验药物制备的质量管理、适度放开申请人/申办者与生产场地的跨境及跨境变更的试点情形的管理建议。Objective:To propose management strategies for sponsors,production sites,and their changes during the clinical research phase of new drugs in China,to provide reference for adapting to the new situation of drug research and development and improving China's drug regulatory policies.Methods:This study analyzed the current issues in the management of sponsors and production sites in the clinical research phase in China,drew on the management experience of foreign regulatory agencies,conducted comprehensive assessment and judgment based on risk principles,and proposed relevant management countermeasures and suggestions suitable for China's national conditions.Results and Conclusion:With the core of ensuring the safety of subjects and the goal of encouraging innovation and improving the accessibility and availability of public medication,this study proposes specifi c management suggestions on strengthening the responsibility of sponsors as the main body,strengthening the quality management of clinical trial drug preparation,the pilot situation of moderately relaxing the crossborder and cross-border changes of applicants/sponsors and clinical trial drug production sites.

关 键 词：新药 临床研究阶段 申办者 生产场地 注册管理 变更管理 

分 类 号：R95[医药卫生—药学]