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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 status quo of quality and safety supervision system of traditional Chinese medicine and the construction of a new regulatory system. Methods Using the methods of literature research and interdisciplinary research, this paper puts forward some suggestions on establishing a new regulatory system of quality and safety of Chinese herbal medicines. Results The current system of quality and safety supervision of Chinese herbal medicines has some problems in terms of legal basis, regulatory body, content and means, and urgently needed to establish a new regulatory system of quality and safety of Chinese herbal medicines. Conclusions Aiming at the existing problems, we should expedite the formulation of the “Chinese Medicine Law” as the main statute, and establish a supporting legal system to formulate operable guidelines on the quality and safety of Chinese herbal medicines. The establishment of the Chinese medicine authority’s dominance in the regulation of Chinese herbal medicines ; Expand the regulatory content of the Chinese Medicine Administration; comprehensive use of legal, economic, administrative, public participation and other means.