Journal of ethnopharmacology
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Review
Non-European traditional herbal medicines in Europe: a community herbal monograph perspective.
The European Directive 2004/24/EC introducing a simplified registration procedure for traditional herbal medicinal products, plays an important role in harmonising the current legislation framework for all herbal medicinal products in the European Union (EU). Although substantial achievements have been made under the new scheme, only a limited number of herbal medicinal products from non-European traditions commonly used in Europe have been registered. Therefore, identification of the obstacles, and determination of appropriate means to overcome the major challenges in the registration of non-European traditional herbal medicinal products are of critical importance for the EU herbal medicinal product market. ⋯ Under the current EU legislation, the requirement to demonstrate 15-year minimum medicinal use in the EU is a major obstacle to the registration of non-European traditional herbal medicinal products. Access to scientific data to support the product safety profile may be a possible solution to overcome the hurdle presented by the 15-year minimum medicinal use period. Furthermore, the Community herbal monographs play an important role in the registration process. Therefore, making full use of existing Community herbal monographs, and promoting scientific research and subsequent development of additional monographs for herbal substances and preparations, and combinations thereof from non-European traditions would be of benefit to herbal medicinal product registration from non-European traditions.