《中药品种保护条例》修订完善的思路探讨  

Discussion on the Revision and Improvement of the Regulations on the Protection of Traditional Chinese Medicine Varieties

作　　者：贺强 马双成[2] HE qiang;MA Shuangcheng(National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products,Beijing 100070,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]国家中药品种保护审评委员会,北京100070 [2]中国食品药品检定研究院,北京102629

出　　处：《中国药学杂志》2023年第24期2213-2216,共4页Chinese Pharmaceutical Journal

摘　　要：根据中药品种保护制度实施期间发现的问题,坚持以问题和临床价值为导向,从突出问题导向、注册管理衔接和以人民为中心等方面,提出修订完善的总体和具体思路,并且从保护范围、与专利制度衔接、激励机制、退出机制、与注册程序衔接等10个方面提出具体建议内容。According to the problems found during the implementation of the protection system of traditional Chinese medicine varieties,adhering to the problem and clinical value as the guidance,from the aspects of highlighting the problem-oriented,registration management convergence and people-centered,the overall and specific ideas of revision and improvement of the system were put forward,and specific suggestions were proposed from ten aspects,such as the scope of protection,the connection with the patent system,the incentive mechanism,the withdrawal mechanism,and the connection with the registration procedures.

关 键 词：中药品种保护 条例修订 总体思路 

分 类 号：R95[医药卫生—药学]