Presentation (CTI)

Problem Statement: Unregistered medicines are routinely imported into Saudi Arabia through regulated pathways to address drug shortages and unmet clinical needs. However, policymakers lacked empirical evidence on what drives the volume of these imports whether shortages alone explain demand, or whether broader therapeutic and market factors play an equally important role. Without this understanding, regulatory responses remained reactive, limiting the system's ability to anticipate supply stress and prioritize registration efforts strategically.
Description: This study used national regulatory data from Saudi Arabia's import clearance system (Faseh) to analyze 19,004 unregistered medicine import entries (2024 - 2025), representing 350.1 million units. Multivariable negative binomial regression was used to identify determinants of import volume per entry. Key predictors included Essential Drug List (EDL) status, shortage history, availability of registered therapeutic alternatives, route of administration, company type, and therapeutic class. Two pre-specified interaction terms assessed whether shortage effects were modified by alternative availability and EDL status.
Lessons Learned: Unregistered medicine importation is not shortage-driven alone it reflects a structured pattern shaped by therapeutic priority, market structure, and supply disruption history. EDL-listed medicines were associated with more than twice the import volume of non-EDL products, demonstrating that clinical priority independently drives importation demand regardless of shortage status. Medicines with registered therapeutic alternatives paradoxically showed higher import volumes, revealing a critical gap between nominal registry presence and functional market availability. The significant interaction between shortage status and alternative availability indicated that even nominally available alternatives provide partial buffering during shortages attenuating but not eliminating the surge in unregistered importation. This distinction has direct policy relevance: expanding the medicine registry is insufficient without ensuring that registered alternatives are actively stocked, distributed, and clinically accessible. Importation analytics can serve as a measurable indicator of pharmaceutical system stress, supporting proactive regulatory planning rather than reactive case-by-case responses.
Stakeholder Perspective: This evidence was generated from a government regulatory perspective, specifically within the Saudi Food and Drug Authority (SFDA). Findings are directly relevant to national regulators and health system planners seeking to strengthen supply resilience, prioritize market authorization, and reduce dependency on unregistered importation pathways. The results support transitioning from reactive importation management toward anticipatory governance using structured importation data to identify registration gaps, guide market entry facilitation programs, and improve pharmaceutical supply resilience across both routine and crisis conditions.