Ecuador

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Ecuador is regulated by the ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria). 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

ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)

Regulatory Pathways (1)

Ecuador MOH Special Import Authorization 30 days

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

Application Form: MOH Ecuador Special Import Form

Legal Basis: Regulated

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

Ecuador

ISO Code	`EC`
Region	Latin America
Regulatory Authority	ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)
Pathways	1 documented
Drugs Available	0 documented