In Saudi Arabia, the standard process for new drug registration is lengthy and complex. To address this, the Saudi Food and Drug Authority (SFDA) has introduced several expedited application pathways and drug designations with shorter approval timelines, providing faster patient access to medicines while maintaining strict regulatory standards.
By strategically selecting the most appropriate procedure, applicants can receive an accelerated assessment for their Marketing Authorization Application (MAA) and achieve an earlier product launch.
In this article, we provide an overview of these fast-track routes for market access. For each, we summarize the purpose, key eligibility criteria, and main advantages for applicants, helping companies plan an efficient regulatory strategy for entering the Saudi market.
Table of contents
Abridged & Verification Pathways
Under the Verification and Abridged pathways, the SFDA operates on a “reliance” model, in which it relies on prior scientific assessments and approvals from other Stringent Regulatory Authorities (SRAs), such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). This model is consistent with World Health Organization (WHO) principles on regulatory reliance, enabling faster access to medicines while maintaining robust standards.
Under these two routes, the SFDA does not simply copy foreign decisions; it builds on existing benefit–risk evaluations, focusing on local context, such as Good Manufacturing Practices (GMP), labeling, stability, and other Saudi‑specific considerations.
The Verification pathway applies to new human and Veterinary medicines that have been approved and marketed by both the EMA and the US FDA. In contrast, the Abridged pathway applies to medicines approved and marketed by either the EMA or the US FDA.
These routes offer the shortest approval timelines among all available pathways in the SFDA. Applications processed via the Verification pathway are typically reviewed within 30 working days, while those under the Abridged pathway are reviewed within 60 working days.
Priority Review
The SFDA also offers a Priority Review pathway, which was introduced in 2014. It aims to expedite the registration of innovative drugs that address serious or life‑threatening conditions. It is also possible for the first biosimilar to come to market, as well as for any shortage drug or those on the SFDA incentive lists.
Under the priority procedure, the SFDA reduces assessment timelines by 40%, helping companies bring essential therapies to Saudi patients faster.
Orphan Drug Designation (ODD)
The SFDA launched the Orphan Drug Designation in June 2023 to support medications with indications for rare diseases. It is available for:
- New drugs
- Already registered drugs, but with a new orphan indication or a new dosage form.
- Major variations that meet the eligibility criteria.
- Drugs that are still under development.
Products granted this designation will receive incentives, including priority review and supportive pricing.
Breakthrough Designation
In Oct 2023, the SFDA rolled out the Breakthrough Medicines Program (BMP), reflecting the Authority’s ability to review and potentially approve innovative medicines still under development, based on strong preliminary data, even when no other regulator worldwide has yet authorized the product.
This designation is intended for promising investigational drugs still in mid-stage development that address serious or life‑threatening conditions. Sponsors participating in this program will gain earlier access to the Saudi healthcare system.
Drug applications can be considered in this designation from the end of Phase II onwards, once there is sufficient clinical evidence to suggest a substantial improvement over existing options. It can be accepted even if the drug dossier requirements are not fully met. The goal is to ensure that patients in Saudi Arabia gain timely access to breakthrough treatments whenever the benefit–risk profile supports approval.
Conditional Approval
The SFDA recognizes that for some serious or life‑threatening conditions, patients cannot always wait for the complete data package usually required for full drug approval. To help address unmet medical needs, the SFDA may grant Conditional Approval for certain promising new medicines, even when data are not yet complete, provided strong preliminary data reflecting benefits outweigh the potential risks.
Companies receiving conditional approval must meet specific post‑approval obligations, such as providing additional quality or clinical data in rolling submissions and within agreed timelines. This ensures that patient access is accelerated while the evidence base continues to strengthen.
RAID Designation
It is a designation launched by SFDA in April 2026 for Research and Investigational Drugs (RAID), dedicated to promoting local clinical trials in Saudi Arabia of drugs that address unmet medical needs. Learn more about it in our article “RAID Designation“.
NADR Designation
It is a new SFDA Accelerator Program for Drugs for Rare Diseases (NADR), an accelerated pathway for pharmaceuticals and biologics targeting rare, life-threatening, or seriously debilitating conditions in Saudi Arabia. Designation can be requested at any stage of development before MAA submission. It provides a package of regulatory and clinical incentives. Learn more in our article, “NADR Designation.”
Special Access Program (SAP)
It is an access mechanism for unregistered medicines intended for patients with serious or immediately life-threatening diseases/conditions for whom satisfactory authorized alternatives are unavailable, unsuitable, have failed, or for whom participation in a clinical trial is not possible. Learn more in our article, “Special Access Program (SAP).”
Named Patient Program (NPP)
Similar to SAP, NPP is an access mechanism for an individual patient/specific case to access an unregistered medicine, subject to SFDA requirements and authorization.
How to Proceed?
At PharmaKnowl, we work with companies to:
- Assess whether their products qualify for specific SFDA designations or fast‑track options.
- Select the most appropriate pathway based on product profile, data package, and timing.
- Plan and prepare the regulatory strategy and the required submissions to fully leverage these opportunities.
If you’re unsure which SFDA pathway or designation best fits your product, or you want an expert view on how to reach the Saudi market faster, we’re here to help. Contact us or schedule a call with our team to discuss your case and explore the most efficient route to approval and patient access.
Summary
| Regulatory Programs | Name of procedure | Eligibility Criteria | Stage of submission |
| Orphan Drug Designation (ODD) | Designation | Life-threatening or serious diseases affecting fewer than 5 in 10,000 people in KSA, with no satisfactory available alternative; the drug must be under development for the orphan condition | Requires pre-submission of a Marketing Authorization Application (MAA) at any stage of development |
| Abridged pathway | Registration pathway | NCE/biologic approved by any one reference agency, i.e., FDA or EMA | Submission of MAA |
| Verification pathway | Registration pathway | NCE/biologic approved by both reference agencies, i.e., FDA and EMA | Submission of MAA |
| Breakthrough Medicines Program (BMP) | Designation | Serious, debilitating, or life-threatening conditions with an unmet medical need, major therapeutic advantage, positive benefit-risk balance, and no prior registration by any regulatory authority. | The request should be submitted by the end of phase 2 or at any time after the submission of the MAA. |
| Priority Review | Registration pathway | New drugs/biologics for serious or life-threatening conditions with unmet medical needs, the first biosimilar to be an innovative product, or eligible unregistred/unabvaialble drugs. | Submission of MAA |
| Conditional review | Approval subject to obligations | Drugs for serious or life-threatening diseases or emergency situations subject to specific conditions and obligations. | Submission of MAA |
| Research and Investigational Drugs (RAID) designation | Designation | Investigational drugs addressing an unmet medical need, under development, not yet authorized by any regulatory authority, with a commitment to conducting clinical trials in KSA. | AT any clinical phase (Phase I, II, III) of drug development |
| Special Access Program (SAP) | Access Mechanism | For unregistered medicines intended for patients with serious or immediately life-threatening disease conditions where satisfactory authorized alternatives are unavailable, unsuitable, have failed, or the patient is unable to participate in clinical trials. | Case-by-case access request, not an MAA submission |
| Named Patient Program (NPP) | Access Mechanism | For access to an unregistered medicine for an individual patient/specific case, subject to SFDA requirements and authorization. | Case-by-case access request, not an MAA submission |
Conclusion
Bringing a new medicine to patients in Saudi Arabia is not just a formal regulatory step; it’s a strategic decision about which SFDA options to use and when to use them. The expedited pathways and designations are powerful options, but choosing the wrong one (or missing an opportunity) can mean avoidable delays and extra work for your team.
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About the Author
Regulatory affairs consultant, with more than 20 years of experience working for the SFDA and the industry.
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