英国人用传统草药药品政策分析

英国是欧盟中第一个启动对传统医药进行立法管理的国家.根据《欧盟传统草药指令》,英国制订了《英国人用传统草药产品法规2005》、《英国传统草药登记方案》等一系列有关传统草药管理的法规、指南等,从传统草药药品的申报、零售、批发、进口及生产各个环节进行管理,以保证安全、有效和质量可控.以英国传统草药登记程序、豁免条件等内容为...

Analysis on regulations of traditional herbal medicinal products for human use in United Kingdom

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.