A Study on the Distinction of Registration Regulations for Herbal Medicines

생약제제의 등록규정 차별화에 관한 연구

Herbal medicines have been used since ancient times as medicines to treat and relieve the symptoms of many different human diseases. However, so far, relatively few herbal medicines have been evaluated scientifically to prove their safety, potential benefits and effectiveness. This study was conducted to provide the groundwork for improving the current registration regulations for herbal medicines in distinction from synthetic medicines. The study was performed based on the literature research and individual interviews with 5 experts who had extensive experience in registration of herbal medicines. When compared with synthetic drugs, herbal medicines exhibit some marked differences, namely the active principles are frequently unknown, standardization, stability and quality control are not easy, they are usually mixtures of complex compounds. Second, the current regulations for herbal medicines are reviewed by comparison of foreign regulation systems like the one in China. The regulation requirements of herbal medicine in China are in distinction from synthetic drugs. The authors conclude that new registration requirements for the herbal medicines should be changed as follows; the toxicity and efficacy data should be submitted as mixed herbal preparation and the documents and other research on the reproduction and generation toxicity need to be shown for the proof of reproduction and generation toxicity, if needed.