Ethiopia

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Ethiopia is regulated by the EFDA (Ethiopian 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

EFDA (Ethiopian Food and Drug Authority)

Regulatory Pathways (1)

EFDA Special Import Authorization – Ethiopia 30 days

Ethiopian Food and Drug Authority special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: EFDA Special Import Form

Legal Basis: Ethiopian Food, Drug and Health Administration Proclamation

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

Reference: EFDA Drug Import Guidelines

Ethiopia

ISO Code	`ET`
Region	Africa
Regulatory Authority	EFDA (Ethiopian Food and Drug Authority)
Pathways	1 documented
Drugs Available	0 documented