摘要
目的:分析我国中药材质量监管政策工具的使用特征,为完善监管政策体系提供参考。方法:采用文本量化分析法,系统梳理2015年以来国家层面发布的中药材质量监管政策。通过构建“政策工具-政策目标”二维分析框架,对政策工具的使用特征进行量化分析,并据此提出优化建议。结果:在32份政策文本中,环境型政策工具使用最多(占64.9%),并以“供应链管理”和“人才队伍建设与技术资源开发”为主要手段;“规范种植养殖,加强源头管理”与“强化上市后质量监管”是当前主要的政策目标。结论:现有政策已覆盖供给、环境、需求3类政策工具,但在4个方面有待完善:源头管理应加强信息公开与技术交流;生产过程质量控制需丰富政策工具类型与数量;上市后监管可设定远景目标并开展国际合作;产业发展需强化基础设施与信息技术建设,并建立成果总结机制。
Objective:To analyze the characteristics of policy tools used in the quality regulation of Chinese herbal medicines in China,and to provide references for improving the regulatory policy system.Methods:A textual quantitative analysis method was employed to systematically review national-level policies on the quality regulation of Chinese herbal medicines issued since 2015.By constructing a twodimensional analytical framework of"policy tools-policy objectives",the utilization characteristics of policy tools were quantitatively analyzed,leading to optimization suggestions.Results:Comprehensive analysis revealed that among the 32 policy documents reviewed,environmental policy tools were the most frequently employed at the national level,with"supply chain supervision"and"talent development and technological resource utilization"as primary approaches.The key policy objectives centered on"standardizing cultivation and breeding practices to enhance source control"and"strengthening post-market quality supervision".Conclusion:The existing policies have covered supply-side,environmental and demand-side policy tools.However,improvements are needed in four areas:source control should strengthen information disclosure and technical exchange;quality control in the production process requires a diversification of policy tools;post-market supervision should establish long-term goals and align with international regulatory standards;and industrial development needs enhanced infrastructure and information technology support,along with a mechanism for summarizing progress.
作者
郗昊
孙阳
刘春生
李向日
王翀
程显隆
魏锋
徐苗
XI Hao;SUN Yang;LIU Chunsheng;LI Xiangri;WANG Chong;CHENG Xianlong;WEI Feng;XU Miao(National Institutes for Food and Drug Control,Beijing 102629,China;Department of Drug Supervision,National Medical Products Administration,Beijing 100037,China;School of Chinese Pharmacy,Beijing University of Chinese Medicine,Beijing 102488,China)
出处
《药学与临床研究》
2026年第1期6-12,共7页
Pharmaceutical and Clinical Research
关键词
政策工具
中药材质量监管
文本量化分析法
优化策略
Policy tools
Quality regulation of traditional Chinese medicinal materials
Textual quantitative analysis method
Optimization strategies
