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