In Japan, Pharmaceuticals and Medical Devices Agency (PMDA) performs both reviews and approval.
The dossier package includes compliance with the GLP that stipulates the standards and procedures that must be followed in the development of a new drug. These include the safety issues and clinical trial procedures.
Given that there is no any application stage that consumes excess time, the application process takes between 1.9 to 2.5 months.
Initial interview meeting
Questions on key issues
The Japan territory does not have any unique issues in Continue reading...