RESUMO
ETHNOPHARMACOLOGICAL RELEVANCE: 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. AIMS OF THE STUDY: The primary aims of this study were to understand the key issues and obstacles to registration of non-European traditional herbal medicinal products within the EU. The findings may identify the need for more attention on the Community herbal monographs elaborated by the Herbal Medicinal Products Committee (HMPC), as well as further evidence based scientific research on non-European herbal substances/preparations by the scientific community. METHODS: A systematic evaluation of the herbal substances and preparations included in Community herbal monographs and public statements has been carried out. The focus was herbal substances and preparations derived from non-European traditions. RESULTS: Of the 109 adopted Community herbal monographs, 10 are herbal substances used in Chinese traditional medicine. Where the HMPC issued a public statement because it was unable to elaborate a monograph more than half-involved herbal substances/preparations from non-European traditions. The main reasons herbal substances/preparations from non-European traditions were not accepted for inclusion in the Community herbal monographs have been identified as due to unfulfilled requirements of Directive 2004/24/EC. The most common reasons were the lack of evidence to demonstrate a 15-year minimum medicinal use period in the EU and evidence of absence of health risk as required by Article 16a (1) (d), and Article 16a (1) (e). CONCLUSIONS: 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.
