미국·유럽연합·중국·일본·한국의 천연물의약품의 인허가제도 비교연구

International Comparison of Natural Product-Derived Drugs Registration Systems: United States of America, Europe, China, Japan and South Korea

In this study, similarities and differences among countries were deduced by surveying the registration regulation for herbal medicinal products in the US, EU, China, Japan and Korea. Natural materials have long been used for the treatment and prevention of diseases in humans, and the development of science and technology has led to the worldwide popularity of new herbal medicinal products. Countries that have laws and regulations on herbal medicinal products are also on the rise. However, there are many cases in which based on specific cultures or customs, and there are difficulties in achieving harmonization internationally because the forms in which the national public healthcare system is reflected in the traditional medicine are different. We surveyed the latest regulations in the target countries through the reports from the literature, web-sites and related institutions. The regulatory and review system for herbal medicinal products in each country were classified into five parts: Definition of Terms; Relevant law and regulations; agency organization; Type of application; Data requirements for approval. This is because different countries have different types and levels of literature supporting the history, origins and periods. In the future, further research will be needed on the causes of the differences among countries which are identified in this study for the advancement of international regulations on herbal medicinal products and international harmonization.