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.

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 EMA and the 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, with a focus on local context such as 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 European Medicines Agency (EMA) and the US Food and Drug Administration (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 and 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 such as priority review and better pricing consideration.

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 as soon as 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 that is 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 fully 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.

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. The expedited pathways and designations described in this article are powerful options, but choosing the wrong one (or missing an opportunity) can mean avoidable delays and extra work for your team.

Regulatory Support

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 submissions required 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.

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