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作 者:罗李娜 陈更新[1,2] LUO Lina;CHEN Gengxin(National Key Laboratory of Dampness Syndrome of Chinese Medicine,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,China;Intellectual Property Management and Transfer Center,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China)
机构地区:[1]广州中医药大学第二附属医院省部共建中医湿证国家重点实验室,广州510120 [2]广东省中医院知识产权管理与转化中心,广州510120
出 处:《中华中医药杂志》2023年第7期3224-3227,共4页China Journal of Traditional Chinese Medicine and Pharmacy
基 金:2021年度广东省和科技部共建中医湿证国家重点实验室重点项目(No.SZ2021ZZ48);广东省中医院中医药科学技术研究专项课题(No.YN2016ML06)。
摘 要:文章针对当前医疗机构中药制剂开发管理的现状,梳理出适应医疗机构中药制剂开发从选题立项逐步到产业化全过程的管理模式,以期为医疗机构中药制剂开发的管理提供参考,并对当前医疗机构存在的共性问题进行探讨,指出医疗机构中药制剂的研发要以临床价值为导向,加快出台与中药新药注册新规相衔接的医疗机构中药制剂法规、研发指导原则,适当提高医疗机构中药制剂开发的经费支持。Based on the current situation of manage for development of Chinese medicine in medical institutions,the article puts forward a suitable management model that adapts the development of Chinese medicine preparations from the selected topic project to industrialization.It will guide the manage for development of Chinese medicine in medical institutions.The article discusses common problems,points out that the research and development of Chinese medicine medical organizations should be clinical value-oriented,speed up for formulating the new drug rules of Chinese medicine on the medical institutions of corresponding laws and regulations,guiding principles,appropriate to improve the support of the development of Chinese medicine.
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