Drug Special Access Program (SAP) in Saudi Arabia

The Special Access Program (SAP), introduced by the Saudi Food and Drug Authority (SFDA), enables patients to access unregistered drugs under development in cases of urgent or life-threatening medical need. This program regulation is comparable to the Named Patient Program, Early Access Programs (EAP), and Compassionate Use programs; it ensures that patients with unmet medical needs can access treatment, even if the drug has not yet been approved in Saudi Arabia.

Understanding SAP

Individual patients who meet certain eligibility conditions can utilize unregistered medicines, biologics, radiopharmaceuticals, and health products under SAP. It is only for very special medical problems and only for cases where:

• The patient is suffering from a serious or life-threatening disease or condition.
• No alternative registered medical products are available locally or have failed and/or are unsuitable for use.
• The unregistered product has demonstrated evidence of efficacy and safety.

SAP is limited to pharmaceuticals and health products. It does not cover medical devices or veterinary products.

Duties and Roles

The SFDA

• Receives and reviews SAP requests submitted by treating physicians or sponsors.
• Depending on the evaluation, considering factors including the nature of the emergency, availability of the therapies, and benefits Vs risks profile of a medicinal product, the SFDA may either approve the request, request additional data, or deny the request.
• Authorizes the sponsor to provide drug-related information to the treating physician.
• Reviews and tracks all the Suspected Unexpected Serious Adverse Reactions (SUSARs) reports provided by the treating physician. 
• Conducts all the risk assessments. 
• Issues import permits for approved drugs, ensuring the legal importation of these substances, and notifying relevant authorities.
• Importantly, SFDA does not comprehensively evaluate the drug’s safety or efficacy; this responsibility lies with the treating physician.

Treating Physician

• Initiates the SAP request in the absence of suitable alternatives.
• The physician must also submit detailed documents such as the medical history rationale, treatment protocol, and monitoring plan.
• The treating physician must obtain informed consent from the patient or guardian, as per ICH guidelines, and inform the patient regarding the potential risks/benefits of receiving therapy.
• Reports all adverse events and provides accountability for product usage to SFDA and the sponsor.
• Physicians must report adverse events in alignment with Pharmacovigilance & QPPV Requirements.

Sponsor/Manufacturer

• The sponsor provides key product documents, including the Investigator’s Brochure and prescribing information.
• Ensures compliance with their own country’s export laws.
• As a final responsibility, the Sponsor must ensure that all SAP-related documents are complete, accurate, and compliant with the SFDA regulations.

SAP Application Pathway

The sponsor can submit the SAP application through their local agent or regulatory consulting representative; in case no sponsor is involved, the treating physician may submit the SAP request themselves or by using a representative such as SFDA-licensed consulting firms.

Pre-Approval Requirements

To initiate the request, these documents must be sent to the Executive Vice President for Drug Affairs at SFDA:

• Signed Arabic-Headed Cover Letter (officially addressed).
• SAP Protocol, which must include:
  • Rationale for use of the investigational drug.
  • Summary of the patient’s condition, medical history, and previous treatment attempts for the disease/condition.
  • Dosing, method of administration, and duration of therapy.
  • Monitoring and safety evaluation methods.
  • Additional product documentation (e.g., foreign prescribing information/package insert).
• Investigator’s Brochure, detailing:
  • Information related to the drug substance and the formulation and structural formula, if any.
  • Summaries of pharmacological and toxicological data in vitro and/or in vivo.
  • Clinical trial results relevant to safety and efficacy.
  • Known risks, side effects, and necessary precautions.
• Informed Consent Form, which must:
  • Clearly state that the patient is participating in SAP voluntarily.
  • Outline the program’s duration and objectives.
  • Describe procedures, risks, and potential benefits to the patients.
  • Provide contact details for inquiries about the program and for reporting any participant injury related to the program.

Sponsors should explore SFDA expedited registration pathways, such as Orphan Drug or Breakthrough Designation.

Post-Approval Requirements

After approval, the physician must submit the following documents to obtain clearance for his named patient(s).

• Official and signed Arabic-headed cover letter from the beneficiary institution administration to the clinical trials department at SFDA.
• SAP Request Form completed and signed by the licensed treating physician.
• Copy of the officially signed Informed Consent (by patient or legal guardian) in accordance with the ICH requirements.
• Any additional documents requested by the SFDA.

SAP Request Workflow

Reporting Obligations

Safety Reporting

• SUSARs must be reported using the CIOMS Form (Council for International Organizations of Medical Sciences) and submitted by the applicant in XML format. However, treating physicians may be exempted from the XML submission requirement.
• Fatal/life-threatening SUSARs must be reported to the SFDA within 7 calendar days in accordance with an ICH-E2A guideline.
• Note: An initial report should be submitted promptly, followed by a detailed follow-up report within 8 calendar days.
• Other SUSARs: within 15 days
• SUSARs must be reported to the National Pharmacovigilance Center with a subject line ‘SAP’. 

Progress Reporting

• Submit program status reports every 3 months or as requested by the SFDA.
• In particular, reports should include:
  • Protocol deviations
  • Additional risks or safety concerns
  • Serious and unexpected adverse drug reactions (ADRs)
  • Emerging safety information to the patient or the program

Product Clearance

After SFDA approval, the sponsor or hospital receives an import letter to clear the product through Saudi customs.

Important Compliance Notes

• Notably, advertising or promoting products under SAP is strictly prohibited.
• SAP is for named patient use only and is not a substitute for formal clinical trials or marketing authorization pathways.
• Depending upon the urgency of the request, SFDA reviews the SAP request within 24 working hours of submission.
• SFDA may permit access to an alternative source of a discontinued drug when it is medically necessary for a serious or life-threatening condition, and no suitable alternative dosage forms or therapies are available.
• Unused or excess medicines from a Special Access Program must be approved by the sponsor and SFDA before reuse for another patient with the same condition, or otherwise returned or destroyed with SFDA notification.

Registration Support

At PharmaKnowl Consulting, our experts provide strategic guidance on Special Access Program (SAP) requests, from eligibility assessment and documentation planning, ensuring alignment with SFDA requirements. We also submit SAPs on behalf of sponsors and provide the drug importer of record (IOR) service. 

Contact PharmaKnowl to streamline your SAP journey.