欧盟成员国传统植物药品注册情况进展

The Progress of the Traditional Herbal Medicines Registration in EU Member States

欧盟是我国中成药出口的重要市场,自2004年颁布实施《传统植物药品注册指令》(2004/24/EC指令)以来,已有1319个传统植物药品种获得上市许可。本文通过对2004-2013年度欧盟各成员国传统植物药品注册受理情况、批准数量、产品特点、治疗领域等进行分析,以期为我国传统中药注册提供帮助。

EU is an important exporting market for Chinese TCM finished productsSince the adoption of the European Directive 2004/EC/24 on Traditional Herbal Medicines in 2004，marketing authorizations have been issued to 1319 productsThis paper analyzes the number of received applications，number of approvals，product features and therapeutic areas of registered products in different EU member countries and aims to provide some insight to Chinese TCM companies wishing to launch their finished products in EU