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

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。

Research Ⅶ on the Changes of Sponsors and Production Sites during theClinical Research Phase of Drugs: Research on the Management Strategiesfor the Sponsors and Production Sites and Their Changes during the ClinicalResearch Phase of New Drugs in China

Objective: To propose management strategies for sponsors, production sites, and their changes duringthe clinical research phase of new drugs in China, to provide reference for adapting to the new situation of drugresearch and development and improving China''s drug regulatory policies. Methods: This study analyzed thecurrent issues in the management of sponsors and production sites in the clinical research phase in China, drew onthe management experience of foreign regulatory agencies, conducted comprehensive assessment and judgmentbased on risk principles, and proposed relevant management countermeasures and suggestions suitable for China''snational conditions. Results and Conclusion: With the core of ensuring the safety of subjects and the goal ofencouraging innovation and improving the accessibility and availability of public medication, this study proposesspecifi c management suggestions on strengthening the responsibility of sponsors as the main body, strengtheningthe quality management of clinical trial drug preparation, the pilot situation of moderately relaxing the crossborderand cross-border changes of applicants/sponsors and clinical trial drug production sites.