文章摘要
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
Research Ⅶ on the Change of Applicants and Production Sites during the Clinical Research Phase of Drugs: Research on the management strategies for the sponsor and production site and their changes during the clinical research phase of new drugs in China
投稿时间：2023-12-11  修订日期：2024-04-22
DOI：
中文关键词: 新药  临床研究阶段  申办者  生产场地  注册管理  变更管理
英文关键词: new drug  clinical research stage  sponsor  production site  registration management  change management
基金项目:
作者单位邮编
杨建红 国家药品监督管理局药品审评中心 100055
王方敏 上海市药品和医疗器械不良反应监测中心 
吴正宇 诺和诺德(上海)医药贸易有限公司 
陈震 郑州大学药学院；沈阳药科大学亦弘商学院 
顾瑶华 苏州工业园区药品管理中心 
连志荣 阿斯利康全球研发中国中心 
芦臣书 百济神州（北京）生物科技有限公司 
于冰 中国外商投资企业协会药品研制和开发工作委员会 
夏雨 扬子江药业集团上海海路生物技术有限公司 
李圆圆 再鼎医药（上海）有限公司 
王宏扬 阿斯利康全球研发中国中心 
武志昂* 沈阳药科大学亦弘商学院 100055
张伟 中国药品监督管理研究会 
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中文摘要:
      目的:为完善我国新药临床研究阶段申办者和生产场地管理及其变更管理提供参考。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完善相关管理对策建议。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/申办者和临床试验药物生产场地的跨境和跨境变更,以及申办者与生产场地的跨境及跨境变更的试点情形的具体管理建议。
英文摘要:
      Objective: To provide a reference for improving the management of sponsors and production sites in the clinical research phase of new drugs in China, as well as their change management. Methods: This study analyzes the current problems in the management of sponsors and production sites in the clinical research phase in China, draws on the management experience of foreign regulatory agencies, conducts comprehensive assessment and judgment based on risk principles, and proposes 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 specific management suggestions on strengthening the responsibility of sponsors as the main body, strengthening the quality management of clinical trial drug preparation, moderately relaxing the cross-border and cross-border changes of applicants/sponsors and clinical trial drug production sites, and the pilot situation of cross-border and cross-border changes of sponsors and production sites.
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