实施《中药品种保护指导原则》对中药品种保护工作的意义和作用

The Effect and Significance of the "Guidelines on Protected Traditional Chinese Medicinal Products" for Working Practice Protected Traditional Chinese Medicinal Products

目的为进一步提高中药品种保护技术审评和监督管理工作水平提供思路和参考。方法结合工作实际,从中药品种保护的申报受理、技术门槛和监督管理等方面,分析和探讨《中药品种保护指导原则》对中药品种保护工作的意义和作用。结果与结论《指导原则》是《中药品种保护条例》[2]颁布实施以来,首次针对中药品种保护工作制定的比较全面的规范性文件,必将对中药品种保护制度的实施产生较为深远的影响。

Objective In order to further improve the work level of Protected Traditional Chinese Medicinal Products technical evaluation,supervision and management,some suggestions and ideas were provided.Methods Based on the working practice and from the aspect of protected declaration acceptance,technical requirements,supervision,management,and etc,the effect and significance of the ＂Guidelines on Protected Traditional Chinese Medicinal Products＂（hereinafter referred to as ＂guidelines＂） were explored.Results and Conclusion ＂guidelines＂ is the first comprehensive and normative document on protecting Traditional Chinese Medicinal Products issued by SFDA,since the ＂Regulations on Protected of Traditional Chinese Medicinal Products＂ had promulgated and enforced,it will certainly produced important effect on the implementation of Traditional Chinese Medicinal Products protected system.