Singapore

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Singapore is regulated by the HSA. 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

HSA

Regulatory Pathways (1)

HSA Special Access Route (SAR) – Singapore 7 days

Singapore's Health Sciences Authority allows access to unregistered therapeutic products via the Special Access Route for individual patients with serious medical conditions, subject to physician application.

Application Form: HSA SAR Application Form

Legal Basis: Health Products Act

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

Reference: HSA Guidance on SAR

Singapore

ISO Code	`SG`
Region	Southeast Asia
Regulatory Authority	HSA
Pathways	1 documented
Drugs Available	0 documented