Japan opens early access pathway

Japan opened a new early access pathway on April 1, the first day of its fiscal year. Tatsuya Kondo, chief executive of Japan's Pharmaceuticals and Medical Devices Agency, likened it to FDA's breakthrough therapy designation and the EU's pilot project on adaptive licensing in a presentation at the BIO Asia conference in Tokyo on March 24.

The aim of the pathway is to speed approval of Japan-discovered drugs, said Kondo. The program is called "Forerunner Review Assignment" in English or sakigake in Japanese, meaning pioneer or explorer. ...