Saudi SFDA updates its SAP guideline for unregistered medicines

What changed

The Saudi Food and Drug Authority (SFDA) has published version 2.0 of its Special Access Program (SAP) guideline, reference DS-G-046. Its document control table lists version 1.0 of 9 September 2019 and version 2.0 of 25 October 2026. The cover page still shows the 2019 publication and implementation dates, so check the effective date with SFDA.

The guideline's own list of changes in version 2.0:

• adds the mechanism for applying for rare disease medicines,
• changes the roles for approval before the program (pre-SAP) and for the import request after approval (post-SAP),
• sets a target of a response within 7 working days,
• updates the process chart and the requirements for ending a program,
• replaces the old forms A, B and C with a new form X.

A medicine qualifies when the patient has a serious, debilitating or immediately life-threatening condition with no satisfactory alternative, the benefits justify the risks, and supply will not get in the way of clinical trials. It must also meet one of three conditions:

• it is registered for the same indication, dose, strength and route with a reference regulatory authority (EMA, US FDA, MHRA, PMDA, Health Canada, Swissmedic or TGA),
• its special access use is approved by one of those authorities,
• it is under registration with SFDA for the same use.

The sponsor files a cover letter with an Arabic heading, the SAP form, a protocol, an investigator's brochure, a consent form and an ethics or pharmacy and therapeutics committee approval with the Clinical Trials Department. SFDA then issues a no-objection letter. The requesting entity or treating physician then asks the Drug Permits Department for the import licence through the Faseh system or by email.

Who it affects

• Saudi hospitals and treating physicians who need an unregistered medicine for a serious condition.
• Sponsors, which the guideline defines as the pharmaceutical company or a delegated vendor that starts, manages and funds the program.
• Overseas suppliers, including Indian exporters, that ship the product.

What it means for buyers

The reference regulator test decides eligibility. A medicine approved only in India does not meet it, although the hospital may ask SFDA about its separate 2025 mechanism for named-patient imports, an Arabic document that was not fully read for this update.

The guideline says the sponsor must meet its own country's export rules, especially for controlled drugs. For an Indian supplier this can mean a CDSCO export NOC or a narcotics export authorisation. After approval, the sponsor reports serious unexpected reactions within 15 days, or 7 days if fatal or life-threatening, sends progress reports every 12 months and accounts for all quantities supplied. Unused stock can go to another patient only with SFDA approval. Advertising medicines supplied through the program is prohibited.

What to do now

1. Confirm the medicine's status with the seven reference regulators before starting a request.
2. Agree who acts as sponsor and who will file the import licence request after the no-objection letter.
3. Ask the Indian supplier early which Indian export approvals the product needs, so they run in parallel.
4. Plan for the 7 working day review plus the import licence and shipping time.

For the wider picture, see the Saudi Arabia import guide and special access routes in the GCC.