Malaysia

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Malaysia is regulated by the NPRA (National Pharmaceutical Regulatory Agency). 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

NPRA (National Pharmaceutical Regulatory Agency)

Regulatory Pathways (1)

NPRA Special Access Scheme – Malaysia 14 days

Malaysia's National Pharmaceutical Regulatory Agency Special Access Scheme allowing access to unregistered medicines for patients with serious or life-threatening conditions.

Application Form: NPRA SAS Form

Legal Basis: Control of Drugs and Cosmetics Regulations 1984

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

Reference: Malaysian Drug Control Authority Act 1984

Malaysia

ISO Code	`MY`
Region	Southeast Asia
Regulatory Authority	NPRA (National Pharmaceutical Regulatory Agency)
Pathways	1 documented
Drugs Available	0 documented