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Pharma Knowledge Base

MFDS Expanded Access Program – South Korea

MFDS EAP ApplicationPharmaceutical Affairs Act Article 34-230 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

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.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

MFDS Expanded Access Guidance

Countries Using This Pathway (1)

KR
Korea (South)
KR
MFDS Expanded Access Program – South Korea
Approval FormMFDS EAP Application
Timeline30 days
Legal StatusPharmaceutical Affairs Act Article 34-2
Source Ref.MFDS Expanded Access Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified