The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.

Japanese company starts pivotal trial with novel molecule as it looks to build oncology presence.

The Japanese environment for cell and gene therapies and regenerative medicine in general continues to be highly supportive. But will pricing pressures under the NHI scheme move to the fore as more expensive products come to market?