Korea (North)

East Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Korea (North) is regulated by the Ministry of Public Health. 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

Ministry of Public Health

Regulatory Pathways (1)

North Korea MOH Special Import Authorization 45 days

North Korea Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH North Korea Special Import Form

Legal Basis: Regulated

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

Korea (North)

ISO Code	`KP`
Region	East Asia
Regulatory Authority	Ministry of Public Health
Pathways	1 documented
Drugs Available	0 documented