英國(guó)是歐盟中第一個(gè)啟動(dòng)對(duì)傳統(tǒng)醫(yī)藥進(jìn)行立法管理的國(guó)家。根據(jù)《歐盟傳統(tǒng)草藥指令》，英國(guó)制訂了《英國(guó)人用傳統(tǒng)草藥產(chǎn)品法規(guī)2005》、《英國(guó)傳統(tǒng)草藥登記方案》等一系列有關(guān)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(bào)、零售、批發(fā)、進(jìn)口及生產(chǎn)各個(gè)環(huán)節(jié)進(jìn)行管理，以保證安全、有效和質(zhì)量可控。以英國(guó)傳統(tǒng)草藥登記程序、豁免條件等內(nèi)容為切入點(diǎn)，對(duì)英國(guó)人用傳統(tǒng)草藥藥品的相關(guān)政策進(jìn)行分析，為意欲進(jìn)入歐盟市場(chǎng)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.