Korea (South)

East Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Korea (South) is regulated by the MFDS (Ministry of Food and Drug Safety). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

MFDS (Ministry of Food and Drug Safety)

Regulatory Pathways (1)

MFDS Expanded Access Program – South Korea 30 days

Korea's Ministry of Food and Drug Safety allows use of unapproved drugs through expanded access for patients with life-threatening diseases who have no other treatment options.

Application Form: MFDS EAP Application

Legal Basis: Pharmaceutical Affairs Act Article 34-2

Eligibility: Serious or life-threatening condition with no locally registered alternative

Reference: MFDS Expanded Access Guidance

Korea (South)

ISO Code	`KR`
Region	East Asia
Regulatory Authority	MFDS (Ministry of Food and Drug Safety)
Pathways	1 documented
Drugs Available	0 documented