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    Japan’s SAKIGAKE Designation System

    This article reviews the latest revision of Japan’s Pharmaceuticals, Medical Devices and other Therapeutic Products (PMD) Act and outlines the history and benefits of the SAKIGAKE designation system. The authors share details about the criteria for SAKIGAKE designation and the procedures and timing of SAKIGAKE designation.   PMD Act Revision History   Prior to 2013, the main regulation for medicines in Japan was called the Pharmaceutical Affairs Law or PAL ....