Key issues in registration of Chinese materia medica in European Union based on "Community Herbal Monograph" / 中草药

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.

Marketing approaches and regulation analysis for Chinese materia medica products in European Union / 中草药

As European Union (EU) is one of the largest herbal markets in the world, EU registration is an important way for the internationalization of Chinese materia medica products. According to the current EU legislation, Chinese materia medica products can access to the EU market in the form of food supplements, drugs, cosmetics, and medical devices. This article discusses the main EU marketing approaches related regulations such as application of food supplements, well-established use (WEU), and traditional use (TU) of medicine. The purpose is to clarify the feasible way of EU registration for Chinese materia medica products and to provide reference for the Chinese enterprises which are aspiring to open up the EU market.