The European Directive 2004/24/EC has introduced a simplified registration procedure for traditional herbal medicinal products which plays an important role in harmonizing the current legislation framework for all herbal medicinal products in the European Union. Although substantial achievements have been made under this directive, only a limited number of herbal medicinal products from non-European traditions commonly used in Europe have been registered. Identification of the obstacles, and determination of appropriate means to overcome the major challenges in the registration of non-European traditional herbal medicinal products (THMP) are important for the EU herbal medicinal product market. Traditional Chinese Medicine (TCM) is one of the major non-European THMP in the European market. Key for acceptance of TCM is the ability to provide scientific evidence combined with a quality control system based on the bioactive ingredients. Modern scientific technology tools are now available to accomplish standardization of TCM products in order to achieve a high level of efficacy and safety, enhancing the introduction into the international markets. Despite the complexity of ingredients and the aspect of synergistic bioactivities in TCM, so far the analysis for quality control was mainly limited to major components for each herb without evidence for a direct relationship with the bioactive components. In a Systems Biology approach, the multi-dimensional chemical and pharmacological approach enables linking of the complex metabolic profile of herbs with biological effects and is, therefore, a key for quality control of TCM material medica, while providing simultaneous scientific evidence for the underlying efficacy and worldwide acceptance of TCM products. The root extract of Dioscorea nipponica is a well-known component in Traditional Chinese Medicine formula's. The bioactivity of this extract has been described in Chinese medicine as: (1) activating blood circulation to dissipate blood stasis (2) promoting qi circulation to relieve pain and muscle tension due to stress (3) relieving internal resistance of stagnant blood. In order to translate the explanatory system-level functionalities in Chinese medicine into a Western biochemical, functional and clinical understanding, an extensive series of pharmacological experiments was used to obtain insights in various effects of prevention and treatment in the cardiovascular domain. Moreover, the active component profile consisting of saponins was studied and found to be of a system synergetic nature. Integrating this information with the outcome of clinical trials in which over 16.000 patients were involved together with results from over 100 million people treated, yielded a systems pharmacological view on the working mechanism and insights in the effectiveness and safety profile of this product produced and controlled under GALP and GMP. This product was the first tHMP herbal medicine product registered in the EU that was produced in China. It underpins a new view on evaluation of herbal medicine products in general and creates an important systems pharmacology concept applicable in a wider sense.
Read full abstract