Drug Special Access Program (SAP) – Saudi Arabia

The Special Access Program (SAP), introduced by the Saudi Food and Drug Authority (SFDA), allows patients to access unregistered drugs in cases of urgent or life-threatening need. This program ensures that patients with unmet medical needs can access treatment, even if the drug approval has not been granted in Saudi Arabia yet.

SAP Introduction

SAP permits the use of unregistered drugs, biologics, and medical products by individual patients who meet specific eligibility criteria. It is strictly reserved for exceptional medical situations and limited to cases where:

• The patient suffers from a serious or life-threatening condition.
• No alternative registered medical products are available locally.
• 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.

Roles and Responsibilities

The SFDA

• Receives and reviews SAP requests submitted by treating physicians or sponsors.
• Depending on the evaluation, the SFDA may approve the request, request additional data, or issue a rejection.
• Issues import permits for approved drugs, ensuring legal importation 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, per ICH guidelines.
• 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.
• The sponsor can also submit the SAP application directly if they are participating in the process.
• 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

Sometimes, a licensed treating physician or the sponsor/manufacturer can submit the SAP application. When no sponsor is involved, the treating physician may submit the SAP request alone.

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.
  • Dosing, method of administration, and duration of therapy.
  • Monitoring and safety evaluation methods.
  • Additional product documentation (e.g., foreign prescribing information).
• Investigator’s Brochure, detailing:
  • Drug formulation and structure.
  • Pharmacological and toxicological data.
  • 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 on a voluntary basis.
  • Outline the program’s duration and objectives.
  • Describe procedures, risks, and potential benefits.
  • Include contact information for patients to ask questions or report adverse events.

Sponsors of designated or exceptional products should explore expedited options, such as Orphan Drug or Breakthrough Designation.

Post-Approval Requirements

After approval, the physician must submit the following documents for product clearance.

• Official Arabic-Headed Cover Letter from the beneficiary institution.
• SAP Request Form completed and signed by the physician.
• Copy of the Signed Informed Consent (by patient or legal guardian) per 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: within 7 days
• Other SUSARs: within 15 days

Progress Reporting

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

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.
• For gene or cell therapies, SAP approval alone may not be sufficient. Sponsors must consult SFDA’s CAR-T/ATMP frameworks for specific classification, GMP, and data requirements.

Registration Support

At PharmaKnowl Consulting, we specialize in regulatory consulting services tailored to SFDA pathways. Our experts provide strategic guidance on Special Access Program (SAP) requests, from eligibility assessment and documentation planning, ensuring alignment with SFDA requirements.

Get in touch with PharmaKnowl today to streamline your SAP journey.