SFDA regulations require a medicinal product to be registered before it can be marketed in Saudi Arabia. The Special Access Program (SAP) is the route for the exception: a patient with a serious or immediately life-threatening condition, no satisfactory authorised alternative, and no clinical trial they can join. The SFDA published its SAP guidance as Version 1.0 on 19 March 2019, implemented 10 October 2019. It sits outside the registration pathways in the SFDA Regulatory Framework for Drug Approval because it authorises supply to a named patient rather than approving a product for the market.
What the Special Access Program is
SAP allows a treating physician to request access to an unregistered medicine for the treatment, diagnosis or prevention of a serious or life-threatening condition where conventional therapies have been considered and ruled out, have failed, are unsuitable, or are unavailable.
SFDA support for a request is explicitly discretionary. Each decision is made case by case, weighing the nature of the medical emergency, the availability of marketed alternatives, and the evidence submitted on the use, safety and efficacy of the drug. There is no entitlement to approval, and no precedent value in a previous grant.
The three SAP criteria
A request must satisfy all three of the following:
- The patient has an acute or chronic serious, or immediately life-threatening, disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat it.
- The potential benefits justify the potential risks of the treatment use, and those risks are not unreasonable in the context of the condition being treated.
- Supplying the investigational drug will not interfere with the initiation, conduct or completion of clinical investigations that could support marketing approval, or otherwise compromise development of the special-access use.
Who initiates a request, and what it contains
The request is initiated by the manufacturer or sponsor, or by the licensed treating physician. Pre-approval submission requires an official signed Arabic-headed cover letter addressed to the SFDA Executive Vice President for Drug Affairs, together with a Special Access Program Protocol.
The protocol must set out the rationale for the intended use, including a list of the therapeutic options that would ordinarily be tried first and an explanation of why the investigational drug is preferable, plus the criteria for patient selection or — for a single patient — a description of that patient.
Timelines
Where all requirements are complete, a special access request is processed within 24 working hours. Requests are then triaged so that the most urgent take precedence, before being forwarded to an assessor for review.
The Clinical Trials Department's business hours are 07:30 to 15:30 (GMT+3), Sunday to Thursday, which is the clock the 24-working-hour target runs against.
Reporting obligations after access is granted
Safety reporting is mandatory and fast. Any Suspected Unexpected Serious Adverse Reaction (SUSAR) must be reported to the SFDA using the CIOMS form as soon as possible and no later than 15 calendar days. If the SUSAR is fatal or life-threatening, the SFDA must be informed no later than seven calendar days, with a follow-up report within a further eight, in line with ICH-E2A.
SUSARs go to the National Pharmacovigilance Center with "SAP" as the email subject, and the applicant must submit in XML format — though a treating physician may be exempted from the XML requirement. Beyond safety reports, the applicant submits written summaries of programme status every three months, and the physician must account for all quantities received to both the SFDA and the manufacturer.
How SAP differs from the accelerated registration routes
SAP is often confused with the SFDA's accelerated pathways, and the distinction matters commercially. SAP authorises supply to a patient; it does not register the product, create market access, or shorten a future registration. The Breakthrough Medicine Program, priority review and conditional approval all sit inside the registration system and end in a marketing authorisation.
For companies, SAP is typically a bridge — a way to meet urgent clinical need in Saudi Arabia while a registration is prepared or a trial is running, not a substitute for either.
How MRG supports Special Access requests
MRG holds SFDA Consultation Office license CO-2023-FO-0022 and supports sponsors through SAP: assessing whether a case genuinely meets the three criteria, preparing the protocol and cover letter, coordinating with the treating physician and institution, and setting up the safety and 3-monthly progress reporting so obligations are not missed after supply begins.
If you are weighing SAP against a registration route, talk to our consultants, or explore our pharmaceutical regulatory services in Saudi Arabia.
Key Takeaway
The Special Access Program gives Saudi patients a route to unregistered medicines when no satisfactory alternative exists, on a discretionary case-by-case basis. Complete requests are processed within 24 working hours, but access brings real obligations: SUSAR reporting within 15 calendar days (seven if fatal or life-threatening), 3-monthly progress summaries, and full accounting for quantities supplied.
Frequently Asked Questions
What is the SFDA Special Access Program?
A route for a treating physician to obtain an unregistered medicine in Saudi Arabia for a patient with a serious or immediately life-threatening condition, where no comparable or satisfactory alternative therapy exists and the patient cannot be enrolled in a clinical trial. SFDA decisions are discretionary and case by case.
How long does an SFDA special access request take?
Where all requirements are complete, the request is processed within 24 working hours, against Clinical Trials Department hours of 07:30 to 15:30 (GMT+3), Sunday to Thursday. Requests are then triaged by urgency and forwarded to an assessor.
Who submits a SAP request in Saudi Arabia?
The manufacturer or sponsor, or the licensed treating physician. The submission requires a signed Arabic-headed cover letter to the SFDA Executive Vice President for Drug Affairs plus a Special Access Program Protocol covering rationale, alternatives considered and patient selection.
What reporting is required after SAP access is granted?
SUSARs must be reported via CIOMS form within 15 calendar days, or seven if fatal or life-threatening with a follow-up within eight more. Reports go to the National Pharmacovigilance Center with subject "SAP". The applicant also submits programme status summaries every three months and must account for all quantities supplied.
