Pakistan

South Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Pakistan is regulated by the DRAP (Drug Regulatory Authority of Pakistan). 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

DRAP (Drug Regulatory Authority of Pakistan)

Regulatory Pathways (1)

DRAP Special Import Authorization – Pakistan 30 days

Drug Regulatory Authority of Pakistan special import authorization allowing import of unregistered medicines for named patients with serious conditions.

Application Form: DRAP SIA Form

Legal Basis: DRAP Act 2012

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

Reference: DRAP Act 2012

Pakistan

ISO Code	`PK`
Region	South Asia
Regulatory Authority	DRAP (Drug Regulatory Authority of Pakistan)
Pathways	1 documented
Drugs Available	0 documented