Enlightenments of Padma Circosan Capsules to registration of compound Chinese materia medica products in European Union 藏药Padma Circosan胶囊对复方中药产品欧盟简化注册的启示

The European Union (EU) law 2004/24/EC has simplified the registration of traditional herbal medicines, which makes it possible for Chinese materia medica (CMM) to enter the EU as medicines. To register CMM products in the EU is an important way to realize the internationalization of CMM. Compound combination is the main clinical application form of CMM under the guidance of CMM syndrome differentiation. How to register compound CMM products in EU has become one of the important realistic topics for the internationalization of CMM. 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 CMM area. The course of this product lead us with the enlightenment for the compound CMM products in three aspects: 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 CMM products; 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 CMM products in EU member states; Applicants should pay more attention to the study of genotoxicity and the systematic collection of post-marketing pharmacovigilance data.