产业视角下中国创新药上市审评审批效率影响因素研究  

Factors Influencing the Efficiency of Review and Approval of Innovative Drugs in China: An Industrial Perspective

作　　者：李鑫悦 何静雯 吴艺 毛睿晨 蒋蓉[1,2] 邵蓉 LI Xinyue;HE Jingwen;WU Yi;MAO Ruichen;JIANG Rong;SHAO Rong(Institute of Regulatory Sciences,China Pharmaceutical University,Nanjing 211198,China;NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation,Nanjing 211198,China)

机构地区：[1]中国药科大学药品监管科学研究院,南京211198 [2]国家药品监督管理局药品监管创新与评价重点实验室,南京211198

出　　处：《中国药学杂志》2025年第2期201-206,共6页Chinese Pharmaceutical Journal

基　　金：2022年中国药品监督管理研究会课题资助(2022-Y-Y-008)。

摘　　要：目的 基于产业视角,识别创新药在审评审批环节效率影响因素,为进一步加强能力建设、加快创新药上市审评审批提供借鉴和参考。方法 运用扎根理论,针对15名具有药品注册工作经验的专家开展半结构式访谈,以Nvivo三级节点编码为牵引,构建中国创新药上市审评审批效率影响因素模型。结果 提炼出14个初始化概念、6个初始范畴及“审评审批机构及队伍建设”“药品上市加速机制”“药品技术指导原则体系”3个主范畴。结论 创新药中国上市审评审批效率受多种因素的制约,产业视角下,药品上市加速机制、审评审批队伍建设、药品审评技术指导原则体系仍有待重点完善与优化。OBJECTIVE To identify the factors affecting the efficiency of the review and approval process of innovative drugs based on the industrial perspective to provide reference for further strengthening the capacity building and accelerating the review and approval of the marketing of innovative drugs.METHODS Using the grounded theory,this study conducted semi-structured interviews with 15 experts in the field of drug registration from March to May 2023,and Nvivo node coding was used as a traction to construct a model of factors influencing the efficiency of China's innovative drug marketing review and approval.RESULTS We have extracted 14 initial concepts,six initial areas and three main areas,i.e.,“review and approval of institutional and team building”“accelerated assessment and approval policies”and“drug technological guidance system”.CONCLUSION The efficiency of review and approval of the marketing of innovative drugs in China is constrained by a variety of factors,and under the industrial perspective,accelerated assessment and approval policies,review and approval team building,and drug technological guidance system still need to be improved and optimized especially.

关 键 词：创新药 审评 审批 扎根理论 影响因素 NVivo 

分 类 号：R951[医药卫生—药学]