Under the Japanese system, there is a lengthy preliminary vetting process before a formal drug or medical device proposal can be filed. The Pharmaceuticals and Medical Devices Agency works with the health ministry to carry out consultations and nonclinical and clinical tests. Only after that can an application be submitted to be followed by a regulatory review and more testing.

The process has public safety in mind. Japanese drug approvals tend to take longer than the U.S. and Europe but some feel the requirements are overly onerous and ill-suited to new technologies.