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 possible, but with assurances of safety and efficacy.