Bahrain

Middle East

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Bahrain is regulated by the NHRA (National Health Regulatory 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

NHRA (National Health Regulatory Authority)

Regulatory Pathways (1)

NHRA Compassionate Use Authorization – Bahrain 14 days

Bahrain's National Health Regulatory Authority compassionate use authorization for access to unregistered medicines for patients with serious conditions.

Application Form: NHRA CU Application

Legal Basis: NHRA Regulatory Framework

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

Reference: NHRA Compassionate Use Guidelines

Bahrain

ISO Code	`BH`
Region	Middle East
Regulatory Authority	NHRA (National Health Regulatory Authority)
Pathways	1 documented
Drugs Available	0 documented