Iran

Middle East

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Iran is regulated by the IFDA (Iran 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

IFDA (Iran Food and Drug Administration)

Regulatory Pathways (1)

Iran MOH Special Import Authorization 45 days

Iran Food and Drug Administration special import authorization for access to medicines not registered in Iran for patients with serious or life-threatening conditions.

Application Form: IFDA Special Import Form

Legal Basis: Iran Food and Drug Act

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

Reference: IFDA Drug Access Policy

Iran

ISO Code	`IR`
Region	Middle East
Regulatory Authority	IFDA (Iran Food and Drug Administration)
Pathways	1 documented
Drugs Available	0 documented