ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Priority Review | Conditional and time-limited approval | Conditional early approval | Sakigake | |
|---|---|---|---|---|
| Nature of program | Designation | Approval Pathway | Approval Pathway | Designation |
| Application Submission Period |
With marketing application submission |
With marketing application |
With marketing application |
Phase of early development (phase 1 or phase 2a trials) |
| Notification Due |
Not specified |
Not specified |
Not specified |
Within 60 days of applicant submission or 30 days of PMDA initiation |
| Features |
Reduce review period from 12 months to 9 months |
Regenerative medicine products only Performing post-marketing studies to confirm efficacy and safety |
Eligible for Priority Review |
Priority Consultation Shorten the period from application to approval Priority Review in 6 months instead of 9 months PMDA appointed concierge |
PMDA: Pharmaceuticals and Medical Devices Agency