• Feature ArticlesFeature Articles

    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 ....
  • Feature ArticlesFeature Articles

    Japan's Conditional Approval Pathway for Regenerative Medicines

    This article discusses the history, reasoning, legal decisions and subsequent regulatory requirements behind Japan's bid to become a world leader in regenerative medicine. The authors outline the process for seeking new regenerative product approvals through an accelerated regulatory pathway and spell out the oversight role played by Japan's regulatory authorities to enable new regenerative, cell-based therapies to be made available to the public in Japan as soon as possi...