Japan embarks on sakigake

Japan has launched the next phase of its ambitious agenda for regulatory transformation, as the Pharmaceuticals and Medical Devices Agency next month will begin reviewing requests for designation under the new sakigake early access pathway that could cut approval times for innovative therapies in half.

Sakigake, formally called Forerunner Review Assignment, is an effort to rapidly turn Japanese innovation into new drugs, devices and regenerative medicines that could cure serious diseases, according to Alberto Grignolo, VP of global strategy and services at Parexel International Corp. The move is part of PMDA's five-year plan, which includes shortening approval times, enhancing safety and further globalizing Japan's pharmaceutical industry...