[关键词]
[摘要]
欧盟2004/24/EC法令对传统草药药品实行简化注册,为中药以药品身份进入欧盟提供了可能,欧盟注册也成为实现中药国际化的重要途径。复方配伍应用是中医辨证思想指导下中药的主要临床应用形式,如何使复方中药产品在欧盟成功注册上市则成为中药国际化的重要现实问题之一。截至2016年底,欧盟各成员国已累计批准630个复方传统草药药品的注册申请,藏药Padma Circosan胶囊是唯一的源于中国传统医药领域的获批复方产品。以该产品为注册实例,系统剖析其审评过程与要点,得出对复方中药产品欧盟注册的3点启示:复方中药产品注册的"非临床"与"临床"申报资料要点为产品安全性资料和传统应用"证据";"相关产品"的传统应用和安全性证据以及欧盟草药专论的有关资料和数据是复方中药产品在欧盟成员国注册审批的重要参考;申请人应重视产品的"致突变性"研究(Ames实验)和上市后药物警戒数据。
[Key word]
[Abstract]
The European Union (EU) law 2004/24/EC has simplified the registration of traditional herbal medicines, which makes it possible for traditional Chinese medicines to enter the EU as medicines. To register traditional Chinese medicine (TCM) products in the EU is an important way to realize the internationalization of TCM. Compound combination is the main clinical application form of TCM under the guidance of TCM syndrome differentiation. How to register compound TCM products in EU has become one of the important realistic topics for the internationalization of TCM. A total of 630 applications for traditional herbal medicinal products have been approved by the EU member states since the implementation of the Directive 2004/24/EC in 2005. Among these products, Padma Circosan Capsules was the only approved one originated from TCM area. The course of this product lead us with the enlightenment for the compound TCM products in three aspects:1) The literatures and evidence about safety and traditional use of "related product" are the core components in the non-clinical and clinical application materials for the registration of both combination and mono-component TCM products; 2) The traditional application and safety evidence of "related products" as well as the relevant materials and data of EU monograph constitute the important content for the registration and approval of compound TCM products in EU member states; 3) Applicants should pay more attention to the study of genotoxicity and the systematic collection of post-marketing pharmacovigilance data.
[中图分类号]
[基金项目]
国家社科基金青年项目(18CGJ036);中国博士后科学基金面上资助项目(2018M633332);四川省科技厅软科学研究项目(2019JDR0106);四川省哲学社会科学重点研究基础——四川医事卫生法治研究中心资助课题(YF18-Q11)