已上市中药生产工艺变更共性问题探讨及对策分析  

Exploration and analysis of common problems and countermeasures in the change of production process of listed Chinese traditional medicine

作　　者：马玲玲 赵兰婷 刘慧 孙明伟 卢雪明 王春芳 杨迎迎 尹宁宁 武海军 MA Lingling;ZHAO Lanting;LIU Hui;SUN Mingwei;LU Xueming;WANG Chunfang;YANG Yingying;YIN Ningning;WU Haijun(Shandong Center for Food and Drug Evaluation Inspection,Jinan 250014,China)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014

出　　处：《药学研究》2025年第3期302-306,312,共6页Journal of Pharmaceutical Research

摘　　要：目的了解已上市中药生产工艺变更的现状和亟须解决的问题,为持有人科学规范开展已上市中药变更研究以及监管部门进行技术审查和监管提供参考。方法通过对山东省已上市中药生产工艺变更过程中的疑难问题进行梳理汇总,分析可能存在的风险和问题,并针对科学规范开展中药生产工艺变更、合理解决问题、有效控制风险进行探讨并提出意见建议。结果本研究结果显示,药品上市许可持有人在中药生产工艺变更过程中存在变更研究验证不充分、变更分类不合理、研究资料缺陷等问题。结论本研究从加强中药生产工艺变更管理提出了合理化建议。药品上市许可持有人应充分履行其主体责任,加强药品质量管理体系建设,借助先进生产技术,持续提升产品质量控制水平,合理开展中药制剂生产工艺变更;药品监督管理部门可通过采取宣贯、培训、案例分享等方式强化监管服务,提升监管人员业务能力水平。Objective To understand the current status and urgent issues to be solved in the change of production process of listed traditional Chinese medicine,providing references for scientific and standardized research on the change of listed traditional Chinese medicine conducted by holders and for the technical review and supervision by regulatory authorities.Methods By sorting out and summarizing the difficult problems in the process of changing the production process of listed traditional Chinese medicine in Shandong Province,analyzing the possible risks and problems,and in view of the scientific and standardized Chinese medicine production process changes and reasonable to solve the problem,discusses the effective control of risks and advice were put forward.Results The results of this study indicate that holders of drug marketing authorization have problems such as insufficient verification of change research,unreasonable classification of changes,and deficiencies in research data during the process of traditional Chinese medicine production process changes.Conclusion This study puts forward reasonable suggestions from strengthening the management of TCM production process change.The holder of drug marketing authorization should fully fulfill its main responsibilities,strengthen the construction of drug quality management system,leverage advanced production technology,and continuously improve the level of product quality control,reasonably carry out changes in the production process of traditional Chinese medicine preparations;Drug regulatory departments can strengthen regulatory services by adopting publicity and implementation,training,case sharing and other ways to improve the business ability of regulatory personnel.

关 键 词：已上市中药 生产工艺变更 变更管理 问题分析 意见建议 

分 类 号：R95[医药卫生—药学]