Accelerating clinical development outside the usual regions for future pandemics: a comparative analysis of COVID-19 therapeutic development between the USA and Japan

Compared with the USA, fewer therapeutics were approved in Japan, and the approvals occurred later. Most therapeutics approved in Japan had previously received EUA in the USA, with Japanese approvals largely dependent on participation in large-scale global studies and the US review schedule. Application data in Japan were primarily based on data from large-scale global studies that had been submitted for the US application; the observed delay in approval was considered attributable to the time required for application preparation. In preparation for future pandemics, it will be necessary to establish systems that take these characteristics into account.