Regulatory review processes are important for the clinical implementation of novel technologies. This review discussed the Japanese regulatory programs for expedited drug development and marketing authorization, such as priority review, conditional approval, SAKIGAKE designation, and council on the development promotion scheme for unapproved and off-label drugs. Particularly, similarities and differences between regulatory frameworks for oncologic drugs in Japan and the USA are mainly described.
Keywords: Conditional approval; FDA; PMDA; Regulation.