The Food and Drug Authority penalizes 23 pharmaceutical establishments for violating the monitoring system

Introduction: The Food and Drug Authority continues its efforts to regulate the pharmaceutical sector

In its ongoing efforts to ensure drug safety and protect public health, the Saudi Food and Drug Authority (SFDA) has released its periodic report on pharmaceutical establishments' compliance with drug availability requirements. The report, covering the monitoring period of February and March, revealed clear violations by 23 pharmaceutical establishments that failed to adhere to the requirements of the electronic pharmaceutical tracking system known as "Rasad.".

Details of violations detected through the “Monitoring” system

The Food and Drug Authority explained that the violations that were detected varied to include several vital aspects that directly affect the availability of treatment for patients, and their details are as follows:

• Strategic stock shortage: Two facilities were found to have failed to maintain a permanent stock sufficient for 6 months of all their registered products, in addition to failing to compensate for the shortage within the maximum allowed period of 3 months.
• Failure to provide products: 7 establishments were involved in failing to provide their registered pharmaceutical products to the market, despite the small quantities required or the low rate of their consumption.
• Delay in reporting shortages: Nine facilities failed to comply with the requirement to report in advance any anticipated shortages or disruptions in drug supplies. The regulations stipulate that reports must be submitted at least six months before the expected supply disruption or stock delay.
• Ignoring direct reporting: 5 facilities were recorded as not complying with direct and immediate reporting of drug movement via the electronic system.

Strict penalties to ensure the stability of the drug market

The Saudi Food and Drug Authority (SFDA) confirmed that the total fines imposed on these violating establishments amounted to SAR 1,232,700. The SFDA emphasized that the Law Regulating Pharmaceutical and Herbal Establishments and Products and its implementing regulations include deterrent penalties that can reach fines of up to five million Saudi Riyals. Penalties are not limited to fines; they also include the possibility of temporarily closing the pharmaceutical establishment for up to 180 days, or even permanently revoking its license, to ensure that such violations, which affect the health of citizens and residents, are not repeated.

General context and historical background of the electronic tracking system “Rasad”

The “Rasad” system is considered one of the most important technological initiatives launched by the Saudi Food and Drug Authority (SFDA) in recent years. This advanced system is designed to track and trace all human medicines from the moment they leave the production lines in factories, through the distribution and transportation stages, until they reach pharmacy shelves and the end consumer. The system relies on the latest global technologies in barcodes and digital tracking, making it a powerful tool for combating commercial fraud and preventing the infiltration of counterfeit or expired medicines into the local market. This step complements the Kingdom's efforts in digital transformation within the objectives of Saudi Vision 2030, which aims to improve the quality of healthcare and secure medical supply chains.

The importance of the event and its expected impact locally, regionally, and internationally

At the local level, this decisive action by the Saudi Food and Drug Authority reflects the Saudi government's commitment to providing a safe and stable healthcare environment. By requiring companies to maintain strategic reserves and report any shortages early, patients are spared the crises of critical drug shortages, thus enhancing public confidence in the healthcare system.

At the regional level, Saudi Arabia is positioning itself as a model for the Middle East in the field of pharmaceutical control. The rigorous implementation of its monitoring system encourages neighboring countries to adopt similar tracking systems, contributing to the reduction of drug smuggling across regional borders and protecting markets throughout the region.

At the international level, this strict adherence to global standards reinforces the Kingdom's position as a trusted partner in the global pharmaceutical supply chain. It also reassures major international pharmaceutical companies that the Saudi market is subject to transparent and fair oversight that protects intellectual property rights and ensures that their genuine products reach patients safely and with full efficacy.