基于持续鼓励创新的药品审评审批优化方向研究  

Research on the optimization direction of drug review and approval based on continuous encouragement of innovation

作　　者：张小勇 高丽萍 牛佳玮 吕心欢 陈圣贤 张象麟 武志昂[1,2] ZHANG Xiao-yong;GAO Li-ping;NIU Jia-wei;LV Xin-huan;CHEN Sheng-xian;ZHANG Xiang-lin;WU Zhi-ang(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;Yeehong Business School,Shenyang Pharmaceutical University,Beijing 100055,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]沈阳药科大学亦弘商学院,北京100055

出　　处：《中国新药杂志》2025年第3期256-263,共8页Chinese Journal of New Drugs

摘　　要：自2015年药品监管新政以来,我国药物创新取得了令人瞩目的发展。本文基于持续鼓励创新的理念,梳理总结既往的成就,并结合现实发展的具体情况,探索研究在新的形势下我国药品审评审批制度的优化方向及其重要与紧迫程度,以期进一步推动鼓励药物创新的审评审批制度改革与发展。本文通过文献研究、比较研究、问卷调研、头脑风暴及专家研讨,提出持续鼓励创新的药品审评审批管理的总体维度和优化方向;采用层次分析法对相关指标进行权重分析,确定优化方向重要性和紧迫性的排序。通过研究最终确立了注册分类、受理、审评程序与审评时限等10个维度以及优化新药定义、优化全球同步开发创新药上市后变更的批准证明性文件要求等35个优化方向,并得出各优化方向的权重值以及重要性和紧迫性排序;其中,重要性排序前3位的是:优化新药定义、优化跨部门沟通协调工作流程及问题解决机制、实施基于风险的分段生产管理;紧迫性排序前3位的为:优化跨部门沟通协调工作流程及问题解决机制、优化新药定义、实施基于风险的分段生产管理。说明这3个方向的问题亟待解决。本研究为监管部门持续优化完善药品审评审批制度体系提供参考。Since the implementation of new drug regulatory policies in 2015,China has achieved remarkable progress in pharmaceutical innovation.With a continuous emphasis on encouraging innovation,it is essential to review and summarize past accomplishments while considering the current development landscape.This will enable the exploration and research of optimizing China's drug evaluation and approval system under the new circumstances,thereby assessing its importance and urgency.The ultimate goal is to further promote the reform and development of a regulatory framework that fosters pharmaceutical innovation.Through literature reviews,comparative researches,questionnaire surveys,brainstorming sessions,and expert discussions,we proposed the overall dimensions and optimization directions for continuously encouraging innovation in drug review and approval management.The analytic hierarchy process(AHP)was employed to analyze the weights of related indicators and determine the ranking of the importance and urgency of these optimization directions.Ours research identified ten key dimensions,including registration classification,acceptance,review procedures,and review timelines.Additionally,35 optimization directions were established,such as refining the definition of new drugs and optimizing the requirements for approval documentation for post-market changes of innovative drugs developed globally in parallel.The study also determined the weight values,importance rankings,and urgency rankings for each optimization direction.The top three in importance are:Refining the definition of new drugs;Optimizing cross-departmental communication and problem-solving mechanisms;Implementing risk-based segmented production management.The top three in urgency are:Optimizing cross-departmental communication and problem-solving mechanisms;Refining the definition of new drugs;Implementing risk-based segmented production management.This study provides a reference for regulatory authorities to continuously optimize and improve the drug evaluation

关 键 词：创新 药品审评审批制度 层次分析法 

分 类 号：R95[医药卫生—药学]