한약제제, 생약제제와 천연물신약의 법규상 개념 및 정의의 문제점과 개선안

• Published in: 大韓韓醫學原典學會誌 Vol. 27; no. 4; pp. 181 - 198
• Main Author: 엄석기(Eom Seok-ki)
• Format: Journal Article
• Language: Korean
• Published: 대한한의학원전학회 30.11.2014; Journal of Oriental Medical Classics
• Subjects: Natural product new drug; Herbal medicinal preparations; Crude drug preparations
• ISSN: 1229-8328

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.