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 |