对欧盟植物药质量标准指导原则的介绍及思考

Introduction and consideration of guideline on specifications of herbal medicines in European Union

欧盟植物药的发展和研发水平在国际上较为领先,植物药法规和质量体系也相对完善。本文通过对欧盟植物药质量标准指导原则及欧洲药典的植物药标准进行介绍,以期为中药新药质量标准的研究和制定提供借鉴,亦为中药欧盟国际注册提供参考。

The research and development level of herbal medicines in European Union ( EU) is leading the world,and the regulations and quality system are relatively perfect. This paper introduces the guideline on specifications of herbal medicines by EU and the corresponding requirements of European Pharmacopoeia,in order to provide reference for the research and establishment of specifications for new traditional Chinese medicines in China,also for the registration of traditional Chinese medicine in EU.