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医疗机构中药制剂开发模式

Development mode of Chinese medicine in medical institutions

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【作者】 罗李娜陈更新

【Author】 LUO Lina;CHEN Gengxin;National Key Laboratory of Dampness Syndrome of Chinese Medicine,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine;Intellectual Property Management and Transfer Center,Guangdong Provincial Hospital of Chinese Medicine;

【通讯作者】 陈更新;

【机构】 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东省中医院知识产权管理与转化中心

【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。

【Abstract】 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.

【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)
  • 【文献出处】 中华中医药杂志 ,China Journal of Traditional Chinese Medicine and Pharmacy , 编辑部邮箱 ,2023年07期
  • 【分类号】R288
  • 【下载频次】83
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