Papua New Guinea

Oceania

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Papua New Guinea is regulated by the TGA PNG (Therapeutic Goods Administration). 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

TGA PNG (Therapeutic Goods Administration)

Regulatory Pathways (1)

TGA PNG Special Access Scheme – Papua New Guinea 30 days

Papua New Guinea's Therapeutic Goods Administration special access scheme for unregistered medicines for patients with serious medical needs.

Application Form: TGA PNG Special Access Form

Legal Basis: Papua New Guinea Drug Regulation

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

Reference: TGA PNG Guidelines

Papua New Guinea

ISO Code	`PG`
Region	Oceania
Regulatory Authority	TGA PNG (Therapeutic Goods Administration)
Pathways	1 documented
Drugs Available	0 documented