2014 Volume 4 Issue 3 Pages 215-221
In order to realize the safe and quick supply of pharmaceuticals, medical devices, etc., “the law which revises the parts of the Pharmaceutical Affairs Law etc.” was proclaimed on November 27, last year. Under the revises of the Pharmaceutical Affairs Law, the package inserts should be prepared based on the newest knowledge, and notified to the Ministry of Health, Labour and Welfare as strengthening of the safety measures concerning pharmaceuticals, medical devices, etc. The construction of the new regulation based on the characteristic about medical devices will be performed. The regenerative medicine is expected as innovative medical treatment recently. To secure prompt and safe provision of regenerative medicine, new framework is needed. In this paper, the circumstances of legal revision, the institutional contents, etc. are introduced especially focusing on the new regulatory system of the regenerative medicine.
