천연물신약 개발에 대한 법적 규제의 적절성에 관한 소고

A Study on the Appropriateness of Legal Regulations on the Development of Natural Product-Derived Drugs

While the economic and time costs of developing new drugs are so high that we can t imagine them, the success rate to final commercialization is extremely small. Natural Product-Derived Drugs discussed in this paper is to develop medicines using natural products extracted from living plants or animals. Natural products have been used as drugs used in human life on the level of traditional medicine during the history of humankind, so the safety and effectiveness of the human body have been confirmed. Therefore, the development of medicines using natural products has the advantage of shortening the development process required for general medicines. In addition, Korea has classified oriental medicine as a separate academic system within the dual system of the medicine, and excellent talents have received the education and are licensed as a oriental medical doctor. Therefore, Korea has an environment suitable for systematic and leading development of Natural Product-Derived Drugs from traditional Korean medicine compared with other countries. Nevertheless, within the current legislation, the definitions of natural products, herbal medicines, and crude drug preparations are different and their scope is unclear, and there are limitations in the development of Natural Product-Derived Drugs by specialists such as oriental medical doctors using traditional Korean medicine. In addition, Korea has deleted the existing preferences that have been granted to the Natural Product-Derived Drugs development process since 2017. For this reason, the current Natural Product-Derived Drugs development process is the same as the general new drug development process, and the situation of slowing down the speed of development Natural Product-Derived Drugs is occurring. This paper examines the process of developing Natural Product-Derived Drugs and the regulations on them, compares the US case with that of Korea, and examines the direction of proper regulation of Natural Product-Derived Drugs development process. In particular, Korea has a legislative system for nurturing oriental medicine with a dual medicine system. Therefore, we will examine how this situation interacts with the legislation on the development of Natural Product-Derived Drugs.