Advances on application of fenugreek seeds as functional foods: Pharmacology, clinical application, products, patents and market.

Trigonella foenum-graecum L. (fenugreek) is one of the oldest applied medicinal herbs. Significant pharmacological and clinical evidence have highlighted the medicinal application of fenugreek. Explore the current knowledge regarding the bioactivity (animal aspects) and clinical application of fenugreek and its bioactive components, as well as the products, markets and patents related to fenugreek. This review highlights the phytochemicals, bioactivity (animal aspects) and clinical application of fenugreek from recent literatures and products, markets and patents from database. Until now, more than 100 phytochemicals have been isolated from fenugreek seeds, mainly including polysaccharides, saponins, alkaloids, phenolic acids, and flavonoids. Fenugreek extract and its bioactive compounds showed excellent antidiabetic activity and anti-obesity activity in animal and human study. Although the fenugreek seed has been used as TCM raw materials for a long time of period in China, China is lacking the research of fenugreek in both depth and width.

Internationalization of Traditional/Complementary Medicine products: market entry as medicine.

Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of traditional approaches that are largely considered lower risk and lower cost than many conventional treatments. While the benefits of internationalization hold clear advantages for the business of T&CM products, keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. At present, the regulations of T&CM products are country specific and largely based on a risk-based assessment with a focus on protecting the consumer. To date, systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of T&CM products were obtained from the relevant regulatory authority's websites for selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, Canada, the European countries and the US). The market entry requirements in terms of quality, safety and efficacy of T&CM products for each country were analyzed and compared. Major differences were identified in the classification of T&CM products, market entry pathways, requirements of compliance with Good Manufacturing Practices; and level of evidence to demonstrate safety and efficacy based on historical use, non-clinical and clinical studies. Variations in the evaluation standards adopted by regulatory authorities pose a number of barriers and opportunities for the internationalization of T&CM products and have great implications for internationalization of TCMs from the sponsors' and the regulators' perspectives.