Objectives : To direct methods of management and development of herbs and their derived products, and at the end of this study to inform the process of making new herbal drug regulations in Korea. Methods : This study analyzed the regulations and laws of western medicine drugs. Results : We have got some herbal prescriptions which are not in the eleven books of oriental medicine now in use but which have proved effective. We need to establish standards for permissions to produce medical products through those prescriptions. Besides, we need the special permissions to produce herbal products through prescriptions, especially those which have been used to treat incurable diseases. And, we can contribute to globalization of oriental medicine and to well situating of herb products and medicinal acupunctures if we produce them according to international standards. It is thought that herbal medicine has no side effect in the medical society in Korea. But, it is getting popular to administer herbal medicine and western medicine together. Thus, the side effects of taking both medicines at the same time should be documented. Conclusions : Herbal medicines and herbal products should be under the control over the whole process of production, circulation, and sales. Now, it is time for herbal medicine to be known to all over the world. Therefore, herbal medicine must meet and adhere to the standards set by the western society and WHO.