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欧盟的植物药发展处于世界领先水平,开拓中成药的欧盟市场对中药国际化具有重要意义,然而当前我国中成药在欧盟的注册面临诸多挑战。首先介绍中成药在欧盟获得药品身份的上市路径,然后对欧盟成员国植物药产品审评总体状况、获批药品的组分特点、植物药专论的应用以及主要适应症等方面进行分析,最终提出我国中成药产品在欧盟通过注册的相关建议。
The EU’s phytomedicine development is at the leading level in the world. It is of great significance for the EU market to open up proprietary Chinese medicines to the internationalization of Chinese medicines. However, the current registration of proprietary Chinese medicines in the EU faces many challenges. First of all, introduce the marketing path of proprietary Chinese medicines in the EU, and then analyze the general situation of the review and evaluation of the botanical drug products in the EU member states, the characteristics of the approved pharmaceuticals, the application of the plant medicine monographs, and the main indications. Finally, Proposed Chinese products in the EU approved the registration of the relevant recommendations.