Advantages of Orphan Drug Designation(ODD) and SAKIGAKE designation are shown. ODD is benefit designation and ODD is highly recommended.
Normal | ODD | SAKIGAKE | |
Application and designation |
NA |
Anytime |
Once a year |
Prioritized PMDA Consultation |
No |
Yes |
Yes |
PMDA Concierge |
No |
No |
Yes |
Rolling submission |
No |
No |
Yes |
Target NDA Review Period |
12 months |
9 months |
6 months |
Extension of Re-examination period (Exclusivity) |
No |
Yes (Max. 10 years) |
Yes |
Grant | No | Yes |
No |