Kuwait

Middle East

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Kuwait is regulated by the KFDA (Kuwait Food and Drug Authority). 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

KFDA (Kuwait Food and Drug Authority)

Regulatory Pathways (1)

KFDA Special Import Program – Kuwait 30 days

Kuwait Food and Drug Authority special import program allowing import of unregistered medicinal products for named patients with unmet medical needs.

Application Form: MOH Kuwait Drug Import Form

Legal Basis: Kuwait Drug Regulation

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

Reference: KFDA Drug Import Guidelines

Kuwait

ISO Code	`KW`
Region	Middle East
Regulatory Authority	KFDA (Kuwait Food and Drug Authority)
Pathways	1 documented
Drugs Available	0 documented