Q&A

In Japan, the marketing authorization of generic products is nominally governed by "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" as well as by the implementing regulation for the Act. In practice, however, almost all of the important issues are governed by numerous notifications from officials at the Ministry of Health, Labour and Welfare. These notifications are directed to other governmental officials, and therefore, have no legal effect on pharmaceutical companies. This means that it is not possible to take legal action against these notifications. The approval process for pharmaceuticals is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA).