ABSTRACT
Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU.
ABSTRACT
The Community Herbal Monograph (CHM) is an official document which reflects the scientific opinion of European Medicines Agency (EMA) and plays an important role in technical harmonization of the herbal medicinal products. The role of CHM is very similar with the centralized procedure in the EU level as it represents the technical coordination results of the assessment about safety and efficacy of herbal medicine. The monograph and national procedure, decentralized procedure, and mutual recognition procedure together constitute the coexistence characteristic of centralization and decentralization of the EU medical legislation. The CHM and the traditional herbal medicine registration also constitute the core content of Directive 2004/24/EC in the EU and member state level respectively. And the CHM plays an important role in the registration of traditional herbal medicinal products in the EU member state. However, it has not yet been fully studied by domestic experts and scholars. This paper makes intensive studies on the value of CHM and analyzes the application of monograph in traditional herbal medicine registration. The purpose is to clarify the value and importance of CHM in the registration of traditional Chinese medicine in EU and to provide reference for the Chinese enterprises which are aspiring to open up the EU market.
ABSTRACT
It is of great importance to bring proprietary Chinese medicines to EU as its herbal medicinal product is world-leading, yet the current status for registrations from China is full of challenges. The routes for registration of herbal medicinal products are introduced at first and then the current registration status on the overall assessment of the products, the characteristics of combinations, the utilization of EU monograph and main indications are analyzed. Suggestions on registering proprietary Chinese medicines are made in the end.
ABSTRACT
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.
ABSTRACT
Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. After 7 years, there is no Chinese medicine to be registered successfully in European market as traditional herbal medicinal products. The thesis gives some ideas to tackle this problem. Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products (EMEA/HMPC/182320/2005) published by European Medicines Agency is an important guidance for traditional herbal products to enter European Community monographs. The thesis introduces and details the procedure as well as gives feasible suggestions about the procedure. It suggests that Chinese medicines enter European Community monographs first, and then apply the registration according to the directive 2004/24/EC. This is an easier access to European market.