欧盟是中药出口的一个关键市场。继欧盟发布《传统植物药注册程序指令》(2004/24/EC)之后,英国颁布的传统草药制品限售法令,使中药在欧盟市场上更加举步维艰。究其根本原因,我国中药产品的生产或注册难以达到欧盟相关标准以及技术法规的要求,特别是其中的重金属超标问题已成为影响中药质量与信誉,阻碍中医药走向世界的一个非常严峻的问题。通过分析欧盟草药药品管理的相关指令及其草药重金属含量标准,并深入分析英国禁令对我国中药出口的影响,提出我国中药企业应对中药出口欧盟重金属含量超标问题的对策。

The EU is a key export market of Chinese materia medica (CMM). Following "The Traditional Herbal Medicinal Products Directive" (2004/24/EC) of EU, the UK enacted the restriction law on the sales of traditional herbs, which made the sales of CMM more difficult in the EU market. The prime reason is that the production or registration of CMM is difficult to meet the standards of the EU relevant technical regulations. In particular, the excess of heavy metals in CMM becomes a very serious problem which has not only influenced its quality and reputation but also has hindered the CMM to the world. By means of analyzing the relevant directives and standards of heavy metals in herbal management of EU, we analyze the impact of the UK ban on CMM exports in depth, and propose the countermeasures of CMM companies, so we can accelerate the internationalization of CMM.