SFDA Sets Faster Regulatory Pathways for Medicines

The Saudi Food and Drug Authority has outlined the Kingdom's experience in building an integrated set of regulatory pathways for medicines and health products, designed to speed patient access to treatments while maintaining strict scientific and regulatory standards across each stage of a medicine's development.

Among the tracks is the promising medicines pathway (مسار الأدوية الواعدة), which accelerates access to innovative therapies backed by strong preliminary evidence while keeping a full benefit-risk evaluation throughout the product lifecycle. A dedicated rare-disease medicines pathway, known as NADR (نادر), offers an accelerated classification track for orphan drugs, with classification decisions issued within 20 working days — a timeframe shorter than typical international practice.

The RAID pathway (مسار تعيين المستحضرات البحثية) supports research products and advanced therapies through early regulatory engagement, providing tailored scientific and regulatory guidance from preclinical stages through clinical development and registration.

The Authority also applies four national marketing-authorization pathways: a standard route for non-innovative drugs with timelines of up to about 335 working days (roughly 469 calendar days); a verification pathway for products already approved by both leading US and European regulators, reviewed within 30 days; an abridged pathway for products approved by either of them, within 60 working days; and a breakthrough programme for highly innovative products not yet registered with stringent authorities, also up to 60 working days.

Starting July 2025, Economic Evaluation Studies (EES) became a requirement in pricing procedures for all therapies subject to pricing, including new registrations, price re-evaluations and renewals, integrating health-technology-assessment elements into the process. Structured review procedures have also been set for advanced therapy medicinal products, combining standard and expedited routes.

For residents and patients in the Kingdom, the framework aims to bring innovative and rare-disease treatments to market faster while safeguarding safety and effectiveness.

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