中药材质量安全新型监管体系构建探讨

The discussion of building a new type of Chinese herbal medicinal quality and safety regulatory system

目的探讨中药材质量安全监管体系现状和新型监管体系构建。方法运用文献研究法、跨学科研究法,提出关于构建中药材质量安全新型监管体系的建议。结果我国现行中药材质量安全监管体系在法律依据、监管主体、内容、手段方面存在问题,急需建立中药材质量安全新型监管体系。结论针对目前存在的问题,加快制定《中医药法》作为主干法规,并建立配套法律体系,制定具有可操作性的中药材质量安全监管指南;确立中医药管理局在中药材监管中的主导地位;扩大中医药管理局监管内容;综合运用法律、经济、行政、公众参与等手段。

Objective To explore the current situation of quality safety （QS） regulatory system of Chinese herbal medicines and the establishment of new - type regulatory system. Methods With the method of literature research and inter - disciplinary re- search, the suggestions on the construction of new - type QS regulatory system of Chinese herbal medicines are offered. Result- s Under the current regulatory system of Chinese herbal medicines, there exist some problems in the legal merit, regulatory bodies, content and means. It is urgent to establish a new - type QS regulatory system of Chinese herbal medicines. Conduslon In response to the existing problems, suggestions are provided, which include ： accelerate the formulation of ＂ Chinese medicine＂ as the main laws and regulations and formulate operational QS regulatory guidelines of Chinese herbal medicines; establish the dominant position of State Administration of Traditional Chinese Medicine in this regulatory system ; expand the scope of regulatory contents of the administration ; employ the concerning methods in an integrated way, such as legal, economic, administrative and public participation.