In a decisive step to ensure consumer protection and the stability of drug supplies in the Kingdom, the Saudi Food and Drug Authority (SFDA) announced the imposition of strict financial penalties on 34 violating pharmaceutical establishments, with total fines exceeding 4.17 million Saudi riyals during January 2024. These measures came as a result of those establishments’ failure to comply with regulatory controls related to the provision of medicines and accurate reporting through the electronic tracking system “Rasad” .
Organizational context: The “Monitoring” system and its role in Vision 2030
The “Rasad” system is one of the most important technological initiatives launched by the Saudi Food and Drug Authority (SFDA) as part of the Kingdom’s digital transformation, in line with Saudi Vision 2030. The system aims to track and monitor all registered human pharmaceutical products in the Kingdom, from their departure from the factory through the supply and distribution chains, until they reach the consumer. The system’s importance lies in enhancing oversight of the pharmaceutical market, combating counterfeit or adulterated drugs, ensuring drug safety and efficacy, and providing accurate data on drug inventory, which helps in making proactive decisions to avoid any potential shortages of essential medicines.
Details of observed violations
The authority's monthly report revealed the variety of violations committed by the sanctioned facilities, violations that directly impact the core of pharmaceutical security in the country. The main violations were distributed as follows:
- 13 facilities: failed to report early on any expected shortages or interruptions in drug supplies, ignoring the regulatory deadline of at least six months before the expected interruption.
- 11 establishments: failed to provide their registered products in the local market, regardless of their prices or consumption rates, which is a clear breach of their responsibilities towards patients.
- 8 facilities: failed to provide direct and accurate reports through the “Monitoring” system regarding the movement of medicines within the supply chains, which negatively affects the accuracy of tracking data and inventory governance.
- Two establishments: did not maintain a permanent stock sufficient for six months for all their products, and did not take the initiative to compensate for the shortage within the specified period of three months.
The importance and expected impact of punitive measures
The significance of these penalties extends beyond their role as deterrent measures. Domestically , this step sends a clear message to all those working in the pharmaceutical sector that the health of citizens and residents is a red line, and that the Authority will not compromise on enforcing regulations to ensure the availability of safe and effective medications. These measures also bolster consumer confidence in the Kingdom's health and regulatory system. Regionally , these stringent regulatory practices position Saudi Arabia among the leading countries in pharmaceutical oversight, potentially serving as a model for other countries in the region to raise their drug safety standards. Internationally , these measures assure global pharmaceutical manufacturers that the Saudi market operates according to the highest international standards, encouraging investment and fostering partnerships based on commitment and quality.
The authority confirmed that the penalties stipulated in the system of pharmaceutical establishments and products may reach a financial fine of 5 million riyals, in addition to other penalties that may include temporarily closing the establishment for a period of up to 180 days, or even canceling the license permanently in cases of serious violations, with the aim of deterring any negligence that affects the health and safety of society.
