欧盟2004/24/EC法令针对传统草药药品实行简化注册程序,很大程度降低了草药药品上市门槛,但法令为其额外设定的注册条件,如草药在欧盟至少药用15年历史要求、适应症限制、给药途径限制等,对非欧洲本土来源的中药产品而言仍面临诸多挑战.鉴于"欧盟草药专论"的评价与草药药品简化注册中安全性和有效性的审评标准基本一致,首次从欧盟草药专论的角度,跟踪欧盟草药专论最新评价进展,对影响欧盟草药专论建立的关键因素以及中药产品简化注册过程中的关键问题进行深入分析,并提出建议与对策,以期为中药产品欧盟注册提供一定指导和参考.

The European Legislation Directive 2004/24/EC introduced a simplified registration procedure for traditional herbal medicinal products, which has largely reduced the difficulty of registration for herbal medicinal products. The traditional Chinese medicinal products still face a lot of challenges such as 15-year minimum medicinal use requirements in the European Union (EU) and limited self-medication indication categories and administration modes. As the criteria for a Community Herbal Monograph assessment is in many aspects similar to assessment of safety and efficacy aspects in the registration of a traditional herbal medicinal product, this article has made a systematic evaluation of the latest assessment of Community Herbal Monograph and presented the key issues in traditional Chinese medicinal product registration based on a Community Herbal Monograph perspective. The results from this article will ultimately contribute to supporting and assisting the non-European traditional herbal medicinal product registration in EU.

国家科技部"十二五"重大新药创制专项资助项目"中药欧盟注册研究"(2012ZX09101231)