MFDS Expanded Access Program – South Korea
Application for Use of Investigational Product for Treatment PurposesPharmaceutical Affairs Act Art. 34(4); Regulation on Safety of Pharmaceutical Drugs Arts. 28-2930 days
Description & Eligibility
Permits use of an unapproved investigational drug for treatment purposes where a patient has a life-threatening or seriously debilitating condition and no alternative therapy is available. MFDS operates two tracks: approval for an individual patient, and approval covering multiple patients.
Eligibility Criteria
Life-threatening or seriously debilitating condition, no available alternative therapy, application made by a treating specialist
Legal Reference / Source
Pharmaceutical Affairs Act (약사법), Korean Law Information Center
www.law.go.kr/법령/약사법Countries Using This Pathway (1)
MFDS Expanded Access Program – South Korea
| Approval Form | Application for Use of Investigational Product for Treatment Purposes |
| Timeline | 30 days |
| Legal Status | Pharmaceutical Affairs Act Art. 34(4); Regulation on Safety of Pharmaceutical Drugs Arts. 28-29 |
| Source Ref. | Pharmaceutical Affairs Act (약사법), Korean Law Information Center |
| Countries | 1 countries |
Compliance Check
Legal Review9/1/2026
Global ValidityVerified