英國是歐盟中第一個啟動對傳統(tǒng)醫(yī)藥進行立法管理的國家。根據《歐盟傳統(tǒng)草藥指令》，英國制訂了《英國人用傳統(tǒng)草藥產品法規(guī)2005》、《英國傳統(tǒng)草藥登記方案》等一系列有關傳統(tǒng)草藥管理的法規(guī)、指南等，從傳統(tǒng)草藥藥品的申報、零售、批發(fā)、進口及生產各個環(huán)節(jié)進行管理，以保證安全、有效和質量可控。以英國傳統(tǒng)草藥登記程序、豁免條件等內容為切入點，對英國人用傳統(tǒng)草藥藥品的相關政策進行分析，為意欲進入歐盟市場的中醫(yī)藥科研單位及制藥企業(yè)提供參考。

UK is the first country in European Union to regulate traditional medicine through legislation. According to the Traditional Herbal Medicinal Products Directive (2004/24/EC), the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005, Traditional Herbal Medicines Registration Scheme (THMRS), and other guidelines were promulgated and put into force. All these regulations and guidelines help to guarantee the safety, efficacy, and quality of traditional herbal medicinal products. Beginning with registration procedures and exemption conditions, this article analyzes the relative medicinal regulations and guidelines in UK and compares these policies with those in China, and finally ends with some countermeasures that might provide certain reference for TCM researchers and pharmaceutical companies.