Importing medicines into the Philippines

The regulator

The Food and Drug Administration Philippines (FDA) regulates medicines through its Center for Drug Regulation and Research. Medicines need a Certificate of Product Registration before they are sold, and every importer needs an FDA License to Operate. Dangerous drugs and controlled chemicals also fall under the Dangerous Drugs Board and the Philippine Drug Enforcement Agency (PDEA), which issue their own permits.

Legal routes for unregistered medicines

Compassionate Special Permit

The Compassionate Special Permit (CSP) is the main route for an unregistered medicine. The FDA's citizen's charter entry for the electronic CSP describes it as a privilege granted to an institution or physician to obtain an unregistered or investigational drug through a licensed importer for a patient, with a specific volume and period of use. The policy was updated by Administrative Order 2020-0028, which extends the CSP to unregistered drugs, vaccines and devices. A CSP is not a product registration and the product cannot be marketed commercially.

There are two forms. A named patient CSP goes to a licensed physician for one identified patient. An institutional CSP goes to a hospital, specialised institution, specialty society or the Department of Health for an expected volume. Both are filed on the FDA eServices portal, and the fee is 500 pesos per patient or per product plus a 1 percent legal research fee.

For a named patient, the application includes the e-application form, the prescribing doctor's CV, the patient's medical abstract, the prescription and proof of payment. For institutional use, it includes a rationale for the volume, proof of approval by another national regulatory authority, the distribution agreement, any clinical study report and proof of payment. The FDA's manual checklist also asks for a written commitment by the authorised specialists to submit a clinical report for every patient, including adverse reactions, and a waiver of FDA responsibility signed by the institution. For an investigational product, the applicant shows the registry entry of an ongoing phase 3 trial of the same product for the target indication.

The physician carries the responsibility for weighing benefit and risk. Renewal of an institutional CSP needs a reconciliation of the volume used, the patients treated and the batch details.

Personal use

Under Joint Circular No. 1 of 22 June 2015, prescription drugs for personal use may enter without prior FDA clearance in the quantity stated on the prescription, in baggage, a balikbayan box or a parcel sent by mail or delivery service, according to the Philippine Embassy in Berlin. The circular does not address unregistered drugs, quantities above the limits are seized, and controlled drugs need PDEA permits. Treat it as a personal allowance, not a supply route for a foreign supplier.

Documents a buyer usually needs

• Compassionate Special Permit, named patient or institutional
• Prescription, medical abstract and the prescribing doctor's CV
• Proof of approval by another regulator and the distribution agreement (institutional use)
• Importer's FDA License to Operate
• Proforma invoice, commercial invoice and packing list with matching names and quantities
• Certificate of analysis for each batch
• Air waybill

Timeline: a worked example

A private hospital in Manila needs an unregistered oncology medicine for one patient, supplied through an FDA-licensed importer.

Total: roughly 2 to 5 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

Air India opened India's first non-stop flight to the Philippines, Delhi to Manila, on 1 October 2025. Other routings connect through Singapore, Bangkok, Kuala Lumpur or Hong Kong. Express courier service is usually 4 to 7 days for small, non-controlled parcels. Air cargo with a customs broker is usually 4 to 10 days including clearance at Manila (NAIA).

CIP and DAP to Manila are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the licensed importer clears the goods against the CSP.

Practical tips for buyers

• Agree which licensed importer will bring the product in before the CSP is filed, since the permit supplies the product through that importer.
• Many medicines for cancer, hypertension, diabetes, mental illness, high cholesterol, kidney disease and tuberculosis are exempt from VAT under the TRAIN and CREATE laws. The BIR list reached 2,263 products under RMC 27-2026 in April 2026 and 2,277 products in August 2026. Products not on the list pay the standard 12 percent VAT.
• World Bank WITS data shows MFN duty of 0 to 5 percent across HS 300490 lines in 2023, about 4 percent on average. Check whether a lower rate applies under the ASEAN India trade in goods agreement with a certificate of origin.
• Keep clinical reports and use records from the start, because the FDA asks for them before renewing a permit.