Amendment of Pharmaceutical Affairs Law

Abstract

Based on the amendment of Pharmaceutical Affairs Law (PAL) which is to be implemented on 25 November 2014, the Ministry of Health, Labour and Welfare is introducing regulations taking into account characteristics of medical device, which will result in acceleration of medical device marketing under more rational regulations. The name of PAL is changed to “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act)”. This change intends to clarify the scope of PMD Act includes medical device.