美国植物制品管理及其启示  

The Management of American Botanical Preparations and Its Enlightenment

作　　者：陈巧[1] 马爱霞[1] 潘勤[2] 

机构地区：[1]中国药科大学国际医药商学院,南京市210009 [2]天津中新药业研究中心,天津市300457

出　　处：《中国药房》2005年第16期1270-1272,共3页China Pharmacy

摘　　要：目的:为我国中药企业开拓美国市场提供参考。方法:从饮食补充剂领域和药品领域两方面出发,概述美国植物制品的管理模式及相关法规政策。结果与结论:我国的中药欲进入美国市场,从近期来看比较现实的做法是采取循序渐进的策略,即首先进行植物标准提取物的研究,然后以饮食补充剂的身份进入美国市场,销售几年以后再提出临床研究申请,最后提出新药申请。OBJECTIVE： To provide references for the expanding of Chinese traditional medicine enterprises in USA market. METHODS：The management mode of the botanical preparations in the USA and the related laws and regulations were overviewed from the perspectives of dietary replenisher and drug areas.RESULTS ＆ CONSCLUSION： For the entry of Chinese traditional medicine into the USA market, a realistic way of behavior for the time being is to adopt a step- by - step policy, i.e. first of all, a research of the standard botanical extracts should be conducted before entering into the USA market in the status of dietary replenishers, then the clinical research application was raised after marketing in USA market for several years,eventually,new drug application was raised。

关 键 词：美国 植物制品 饮食补充剂 药品 管理 

分 类 号：R95[医药卫生—药学]