Pediatric drug development in Japan: Current issues and perspectives.

The number of clinical trials in Japan that aim to obtain regulatory approval for new drugs and devices has increased for adults, but not children. The following reasons have been proposed for this discrepancy: the wide range of ages from newborns to adolescents, requirements for many drug formulations, the difficulties associated with obtaining consent, and less profit for companies. The processes required to obtain regulatory approval for drugs and devices, particularly in the pediatric field, differ among Japan, Europe, and the United States (US). While clinical trials are not necessarily required for the development of new drugs or obtaining additional indications in Japan, laws in Europe and the US require clinical trials on children for newly developed drugs; however, pharmaceutical companies are entitled to a 6-mo extension for a patent when pediatric data are added to the attached documents for clinical trials. We herein discuss the current status of and issues associated with pediatric drug development, including clinical trials, in Japan as well as future perspectives.