ICH
Question one
In Japan, Pharmaceuticals and Medical Devices Agency (PMDA) performs both reviews and approval.
Question two
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.
Question three
Given that there is no any application stage that consumes excess time, the application process takes between 1.9 to 2.5 months.
Question four
Application
Initial interview meeting
Questions on key issues
Expert review
Review report
PAFSC evaluation
Approval
Question five
The Japan territory does not have any unique issues in
Continue reading...