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经典名方及其政策法规历史沿革OA

Historical Evolution of Classical Famous Formulas and Their Policy Regulations

中文摘要英文摘要

经典名方作为中医药体系的典型方剂,是经过长期临床实践检验和经验积累所得,在传承中医药核心理论、夯实临床应用基础、彰显中医药诊疗特色方面具有独特价值.自2007年被纳入新药研发范畴以来,国家持续加大扶持力度,多项政策法规陆续出台,为经典名方制剂的研发、审评与转化提供了制度保障,使其始终备受关注.经过十余年发展,部分经典名方制剂已获批上市,开发工作进入实质性推进阶段.开发科技含量高、临床疗效确切、质量标准优良的古代经典名方复方制剂,对提升中医药服务能力、推动中医药传承创新具有重要意义.通过梳理近年来相关文献及政策文件,对其国内外发展形势、政策法规历史沿革及发展现状进行综述,并结合产业发展及研究存在的问题展开讨论,以期为经典名方的高质量发展提供参考.

Classical famous formulas,as exemplary formulations within the traditional Chinese medicine(TCM)sys-tem,have been refined through long-term clinical practice and accumulated experience.They hold unique value in inher-iting the core theories of TCM,strengthening the foundation for clinical application,and highlighting the distinctive fea-tures of TCM diagnosis and treatment.Since their inclusion in the scope of new drug research and development in 2007,the state has continuously increased support,with multiple policies and regulations successively introduced,provi-ding institutional safeguards for the development,evaluation,and transformation of classical formula preparations-keep-ing them consistently in the spotlight.After more than a decade of development,some classical formula products have been approved for market release,marking a substantive advancement stage in their development.Creating compound preparations of ancient classical formulas with high technological content,definite clinical efficacy,and excellent quality standards is of great significance for enhancing the service capacity of TCM and promoting its inheritance and innova-tion.By reviewing relevant literature and policy documents in recent years,this article summarizes the domestic and in-ternational development landscape,the evolution of policies and regulations,as well as the current development status.It also discusses existing challenges in industrial development and research,aiming to provide references for the high-quality development of classical famous formulas.

铁昌存;王丹妮;郑顺亮;务勇圣;颜冬兰;陈安平

天津中医药大学,天津 301617天津中医药大学,天津 301617||九芝堂股份有限公司,北京 101300天津中医药大学,天津 301617||九芝堂股份有限公司,北京 101300天津中医药大学,天津 301617||九芝堂股份有限公司,北京 101300九芝堂股份有限公司,北京 101300天津中医药大学,天津 301617||九芝堂股份有限公司,北京 101300

医药卫生

中医药经典名方国内外形势政策法规

Traditional Chinese MedicineClassical Famous FormulasDomestic and International SituationPolicies and Regulations

《亚太传统医药》 2026 (4)

6-11,6

10.11954/ytctyy.202604002

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