일본 의약품 제조판매승인제도에 관한 연구

In 2005, Japan introduced the Pharmaceuticals Marketing Approval System in order to secure the safety and effectiveness of the pharmaceuticals. When a pharmaceuticals manufacturer/distributor applies for a marketing approval to the PMDA, the PMDA conducts a reliability survey followed by an approval examination. When the PMDA notifies the Minster of Health, Labour and Welfare of the approval examination report after such examination process, the Minster of Health, Labour and Welfare decides whether to approve it or not after consulting the Pharmaceutical Affairs Council. Such Marketing Approval System in Japan offers several implications. First, the Pharmaceutical Affairs Act in Korea contains provisions related to permission and notification for manufacturing and distribution of each item for pharmaceuticals, but provisions related to pharmaceuticals examination are not included. Examination is important for permission and notification for manufacturing and distribution of each item for pharmaceuticals, so there is a need to prepare examination provisions. Second, the National Institute of Food and Drug Safety Evaluation is conducting tasks related to pharmaceuticals examination in practice, but there are no related provisions in the Pharmaceutical Affairs Act. This indicates that the National Institute of Food and Drug Safety Evaluation is conducting such tasks related to pharmaceuticals examination with no legal basis. Therefore, it is necessary to establish a legal basis for the examination agency in the Pharmaceutical Affairs Act to strengthen pharmaceuticals examination capacity and to solidify independence from the Minister of Food and Drug Safety, which is the licensing agency. Third, the PMDA is conducting various investigations related to the pharmaceuticals marketing approval based on the Act on Pharmaceuticals and Medical Devices. Korea is also conducting diverse investigations regarding permission for manufacturing and distribution of each item for pharmaceuticals, but there is no legal basis for this. Therefore, it is required to prepare a legal basis for the investigations related to pharmaceuticals examination. Fourth, legislative improvements for expanding personnel for pharmaceuticals examination and strengthening expertise must be established in order to secure the expertise and reliability of pharmaceuticals examination.