Single Patient IND in Saudi Arabia
How the single patient ind pathway operates in Saudi Arabia.
About Single Patient IND
US FDA single-patient Investigational New Drug authorization.
How Single Patient IND 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 Single Patient IND 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.