Philippines

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways
3. Available Drugs

Regulatory Overview

Philippines is regulated by the FDA Philippines (Food and Drug 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

FDA Philippines (Food and Drug Administration)

Regulatory Pathways (1)

FDA Philippines Compassionate Special Permit (CSP) 21 days

FDA Philippines issues Compassionate Special Permits for unregistered drugs needed by individual patients with serious or life-threatening diseases who have no other treatment options.

Application Form: CSP Application Form

Legal Basis: RA 9711 FDA Act 2009

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

Reference: FDA Philippines CSP Guidelines

Drugs Available (1)

Drug	Access Route	Status	Lead Time
diethylcarbamazine	—	—	—

Philippines

ISO Code	`PH`
Region	Southeast Asia
Regulatory Authority	FDA Philippines (Food and Drug Administration)
Pathways	1 documented
Drugs Available	1 drug(s)