OrphanDrug
OrphanDrug
Pharma Knowledge Base

FDA Philippines Compassionate Special Permit (CSP)

CSP Application FormRA 9711 FDA Act 200921 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

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.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

FDA Philippines CSP Guidelines

Countries Using This Pathway (1)

PH
Philippines
PH
FDA Philippines Compassionate Special Permit (CSP)
Approval FormCSP Application Form
Timeline21 days
Legal StatusRA 9711 FDA Act 2009
Source Ref.FDA Philippines CSP Guidelines
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified