ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Customized Examination | Priority Screening | Conditional Approval | |
|---|---|---|---|
| Nature of program | Designation | Designation | Approval Pathway |
| Application Submission Period |
Before marketing application |
With marketing application |
With marketing application |
| Notification Due |
Within 30 days |
Not specified |
Within 90 days |
| Features |
Preliminary examination by receiving approval documentation in advance according to the developer’s schedule |
Quicker examination and reduction of civil petition processing compared to other drugs by designating personnel exclusive for the task |
Approval with Phase 2 data on the condition that a therapeutic confirmation (Phase 3) clinical trial will be performed after commercialization to expand treatment opportunities for patients with cancer and rare diseases |
MFDS: Ministry of Food and Drug Safety