MFDS Marketing Authorisation & Orphan Drug Designation – South Korea
Orphan Drug Designation Recommendation (희귀의약품 지정 추천서)Regulation on Designation of Orphan Drugs Arts. 3-4 (MFDS Notice 2026-8); Pharmaceutical Affairs Act Art. 2(18)
Description & Eligibility
Standard route to market. The Ministry of Food and Drug Safety grants marketing authorisation, and separately designates orphan drugs (희귀의약품). Designation requires a domestic patient population of 20,000 or fewer, or an equivalent unmet-need ground, and the Korea Orphan & Essential Drug Center issues the designation recommendation that supports the application.
Eligibility Criteria
Domestic prevalence of 20,000 patients or fewer, or no alternative treatment available, or markedly improved safety/efficacy over existing alternatives
Countries Using This Pathway (1)
MFDS Marketing Authorisation & Orphan Drug Designation – South Korea
| Approval Form | Orphan Drug Designation Recommendation (희귀의약품 지정 추천서) |
| Legal Status | Regulation on Designation of Orphan Drugs Arts. 3-4 (MFDS Notice 2026-8); Pharmaceutical Affairs Act Art. 2(18) |
| Source Ref. | KODC — Orphan Drug Designation Recommendation |
| Countries | 1 countries |
Compliance Check
Legal Review9/1/2026
Global ValidityVerified