Special Access Scheme in Saudi Arabia
How the special access scheme pathway operates in Saudi Arabia.
About Special Access Scheme
Australia's TGA-operated pathway for unapproved therapeutic goods.
How Special Access Scheme 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 Special Access Scheme 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.