Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process. The objective of this research is to examine and document the shared encounters involving remote inspections and evaluations carried out by SFDA from 2020 to 2022. This will be achieved through the evaluation of the accuracy of document evaluation and the extent to which the objectives of smart GxP inspections were met. Data were collected from local and international smart inspections reports conducted by SFDA between 2020 and 2022, covering medical device manufacturers, pharmaceutical manufacturing sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The results indicate that smart GxP inspections were effective in achieving visit objectives, showing a high degree of document evaluation accuracy. The findings of this study support the use of smart GxP inspections as a valuable alternative to on-site inspections, offering a practical solution to regulatory compliance during the pandemic and beyond. Although the SFDA recognizes the usefulness of smart inspections in upholding regulatory oversight in the face of various challenges, it does not endorse the complete replacement of conventional on-site inspection methods. The SFDA acknowledges significant limitations associated with the current technological resources used in remote regulatory assessments, and these limitations will be explored in the relevant sections.

Drug shortages in Saudi Arabia: Root causes and recommendations.

Drug shortages are a multifaceted problem that has been recurring in Saudi Arabia over the past decade with its significant negative impact on patient care. However, there is a dearth of evidence about possible domestic reasons, if any, behind this recurring problem. Recently, the Pharmacy Education Unit at King Saud University College of Pharmacy has called for a meeting with multiple stakeholders from academia, pharmaceutical care, pharmaceutical industry, purchasing and planning, and regulatory bodies to unveil the root domestic causes of the drug shortages in the Kingdom. Four major topics were used to guide the discussion in this meeting, including: current situation of drug shortages in Saudi Arabia, major factors contributing to drug shortages, challenges and obstacles to improve drug supply, and stakeholders' recommendations to manage drug shortages. The meeting was audio-recorded and transcribed into verbatim by five authors. The text was then reviewed and analyzed to identify different themes by the first and third authors. Multiple causes were identified and several recommendations were proposed. The main domestic causes of drug shortages that were explored in this study included poor medication supply chain management, lack of government regulation that mandates early notification of drug shortages, a government procurement policy that does not keep pace with the changes in the pharmaceutical market, low profit margins of some essential drugs, weak and ineffective law-violation penalties against pharmaceutical companies and licensed drug importers and distributors, and overdependence on drug imports. The participants have also proposed multiple recommendations to address drug shortages. Policy makers should consider these factors that contribute to drug shortages in Saudi Arabia as well as the recommendations when designing future initiatives and interventions to prevent drug shortages.