中药产品欧盟上可行途径和法规解析.PDFVIP

中草药 Chinese Traditional and Herbal Drugs 第 45 卷 第 5 期 2014 年 3 月 ·603 · ·专 论 · 中药产品欧盟上市可行途径及法规解析 1 1* 2 2 瞿礼萍 ，邹文俊 ，姬建新 ，李伯刚 1. 成都中医药大学，四川 成都 610041 2. 成都地奥制药集团有限公司，四川 成都 610041 摘 要：欧盟作为全球最大的植物药市场，是中药产品进军国际市场的重要目标。根据欧盟现行法规，中药产品可以食品补 充剂、药品、化妆品和医疗器械的形式进入欧盟市场。通过对食品补充剂、药品固有应用（WEU ）和药品传统应用（TU ） 申请等中药产品的主要上市途径以及相关欧盟法规进行简要解析，明确中药产品在欧盟上市的可行途径，以期为国内有志开 拓欧盟市场的中药企业提供一定借鉴。 关键词：中药产品；欧盟；食品补充剂；药品固有应用申请；药品传统应用申请 中图分类号：R288 文献标志码：A 文章编号：0253 - 2670(2014)05 - 0603 - 05 DOI: 10.7501/j.issn.0253-2670.2014.05.001 Marketing approaches and regulation analysis for Chinese materia medica products in European Union 1 1 2 2 QU Li-ping , ZOU Wen-jun , JI Jian-xin , LI Bo-gang 1. Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China 2. Chengdu Di’ao Pharmaceutical Group, Chengdu 610041, China Abstract: As European Union (EU) is one of the largest herbal markets in the world, EU registration is an important way for the internationalization of Chinese materia medica products. According to the current EU legislation, Chinese materia medica products can access to the EU market in the form of food supplements, drugs, cosmetics, and medical devices. This article discusses the main EU marketing approaches related regulations such as application of food supplements, well-established use (WEU), and traditional use (TU) of medicine. The purpose is to clarify the feasible way of EU registration for Chinese materia medica products and to provide reference for the Chinese enterprises which are aspiring to open up the EU market. Key words: Chinese materia medica product; European Union; food supplements; well-established use of medicine; traditional use of medicine 欧洲议会和欧盟理事会颁布的传统草药药品法 甚至一度误认为尚未注册成