Administrative Order No. 2025-0024

Guidelines in Availing Compassionate Special Permit for the Restricted Use of Covered Pharmaceutical Products and Medical Devices for Human Use

Download the policy issuance: A.O. No. 2025-0024 dated November 19, 2025

Signed and issued by the Secretary of Health, aims to update guidelines for availing CSP from the Food and Drug Administration (FDA), and applies to qualified insltitutions, DOH-licensed hospitals, specialty societies, and licensed physicians (as CSP Holders and applicants). Includes as annexes to issuance forms on CSP Post-Approval Commitment Compliance for pharmaceutical products and vaccines, and medical devices and medical equipment; CSP Benefit-Risk Assessment for use of vaccines; and CSP Post-Approval Importer Report.

Repeals prior issuances including A.O. No. 4, s. 1992 (CSP Permit Requirements), A.O. No. 2005-0008 (Restricted Use of HIV and AIDS Drugs and Test Kits), A.O. No. 2020-0028 (Amendment to A.O. No. 4, s. 1992), FDA MC No. 2015-008 (CSP for Registrable Medical Devices), and Subsection V.7 of A.O. No. 2018-0002 (Authorization for Medical Device based on ASEAN Harmonized Technical Requirements).

Did not originate from HFDB: Address further inquiries about this policy issuance to the FDA.

See also:

• R.A. No. 3720 (Food, Drug, and Cosmetics Act)

• R.A. No. 9711 (FDA Act of 2009, amending R.A. No. 3720)