Myanmar

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Myanmar is regulated by the FDA Myanmar (Food and Drug Administration). 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

FDA Myanmar (Food and Drug Administration)

Regulatory Pathways (1)

Myanmar MOH Special Import Authorization 45 days

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

Application Form: MOH Myanmar Special Import Form

Legal Basis: Regulated

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

Myanmar

ISO Code	`MM`
Region	Southeast Asia
Regulatory Authority	FDA Myanmar (Food and Drug Administration)
Pathways	1 documented
Drugs Available	0 documented