The Food and Drug Administration (FDA) of the Philippines has issued updated guidelines for applying for a Compassionate Special Permit (CSP), enabling access to pharmaceutical products and medical devices that are not registered in the Philippines but are necessary for restricted, compassionate use. This Order aims to facilitate access to critical therapeutic interventions in urgent medical cases.
Scope
Summary of the FDA’s guidelines for availing the Compassionate Special Permit (CSP) for pharmaceutical products and medical devices required for restricted use in life-threatening conditions, rare diseases, and emerging infectious diseases.
Key Highlights
What is a Compassionate Special Permit (CSP)?
A CSP allows qualified applicants to access unregistered pharmaceutical products or medical devices through FDA-licensed establishments or via a donor for restricted, patient-specific use.
Who Can Apply?
- Licensed physicians
- DOH-licensed hospitals
- Specialty medical societies
Covered Conditions
- HIV/AIDS, cancer, and other life-threatening conditions
- Emerging infectious diseases and rare diseases
- Diseases declared by the World Health Organization (WHO)
Acceptable Registration Statuses for Medical Devices
- Medical devices not yet registered in the Philippines but NDRA registered in the country of origin.
- No CSP will be issued for previously used or refurbished medical devices.
General Application Requirements
- Applications must be submitted through the FDA eServices Portal.
- Applicants must provide names and addresses of authorized medical officers, specialists, and patient names (for Named Patient Use), subject to FDA validation.
Application Processing
7 working days for application processing, with extensions allowed under the Ease of Doing Business Act.
Fees
The application fee for a CSP is Php 510.00.
Repealed Issuances
This Order repeals and replaces previous CSP-related issuances (e.g., AO No. 4 s. 1992, AO No. 2020-0028).
Attachment
See the full Administrative Order No. 2025-0024 document on CSP Guidelines (provided in English).
Implications to Clients
Medical device establishments (manufacturers and distributors) may support hospitals and physicians in providing access to unregistered medical devices for compassionate use, ensuring that the devices are new and NDRA registered.
Devices authorized under a CSP must be used strictly for patient-specific, restricted purposes and must not be marketed or sold commercially.
Physicians, hospitals, or medical societies must comply with the approved indication and scope of use.
Effective Date
This Order shall take effect fifteen (15) days after publication in a newspaper of general circulation and upon filing of three (3) certified copies with the University of the Philippines Law Center.
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.
