Named Patient Program (NPP) in Saudi Arabia

About Named Patient Program (NPP)

The foundational pathway for providing individual patients access to drugs not yet registered in their country.

How Named Patient Program (NPP) works in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) operates a Personal Import / Unregistered Medicine pathway for named patients, typically requiring physician justification and hospital ethics-committee review.

Patients in Saudi Arabia seeking access under Named Patient Program (NPP) typically follow this flow: a licensed physician in Saudi Arabia issues the prescription and clinical justification, the regulator reviews and authorises, and an authorised operator coordinates import.

Documents required in Saudi Arabia

• Physician prescription and clinical-justification letter.
• Patient identification and consent.
• Country-specific NPP/personal-import form.
• Hospital or clinic attestation where required.

Typical timeline

End-to-end 2-6 weeks in most tier 1 jurisdictions. Cellular and gene therapies may require additional ethics-committee review.

Start a request

Start a request under Named Patient Program (NPP) in Saudi Arabia