The Food and Drug Authority fined 34 establishments 4 million riyals for violating the monitoring system
In a decisive step reflecting the regulatory authorities' keenness to protect drug security in the Kingdom of Saudi Arabia, the Saudi Food and Drug Authority announced the imposition of strict financial penalties on 34 pharmaceutical establishments, after detecting regulatory violations during January 2026. The total value of the fines amounted to 4,175,400 riyals, as a result of these establishments' breach of drug availability controls and their failure to report immediately through the approved electronic tracking system "Rasad".
The "Monitoring" system: a cornerstone of national drug security
These measures come within the framework of the Kingdom's ongoing efforts to strengthen the public health system, with the electronic "Rasad" system being one of the most important digital transformations in the health sector. This system aims to track the journey of medicines from the production line in factories until they reach the consumer, ensuring the safety of pharmaceutical products and preventing commercial fraud. Adherence to this system is a fundamental standard for ensuring the stability of local pharmaceutical supplies, making any manipulation of it a direct threat to patient health and the stability of the pharmaceutical market.
Details of the violations: Negligence in reporting and shortage of stock
The Authority’s monthly report revealed the diversity of violations that warranted punishment, with 13 facilities topping the list for failing to comply with early reporting of expected shortages or interruptions in drug supplies, ignoring the regulatory deadline that requires reporting 6 months before the expected time of interruption, which hinders the ability of health authorities to take proactive measures.
The inspection teams also identified 11 other facilities that failed to provide their registered products in the Saudi market, regardless of cost or consumption rates, a clear violation of their professional and ethical obligations to patients. In a related matter, the list included 8 facilities that failed to report directly and accurately on the movement of medications within their supply chains, negatively impacting the accuracy of tracking data and inventory management.
The importance of commitment and its impact on the health sector
The importance of these penalties extends beyond the financial aspect; they also serve as a strong deterrent, ensuring the continued availability of treatment for citizens and residents. Pharmaceutical establishments' adherence to regulations directly contributes to preventing the black market and guaranteeing the uninterrupted supply of essential medications, particularly those for chronic diseases. Experts emphasize that the strict enforcement of these regulations enhances consumer confidence in the Saudi healthcare system and raises quality standards in the private sector.
Penalties may include license revocation
In cases related to strategic stockpiling violations, the Saudi Food and Drug Authority (SFDA) penalized two establishments for failing to maintain a six-month supply of all their products and for not replenishing the shortage within the maximum three-month period. The SFDA emphasized that penalties, according to the regulations governing pharmaceutical establishments and products, can reach fines of up to 5 million riyals, in addition to administrative measures including temporary closure of the establishment for up to 180 days, or even permanent license revocation in cases of serious violations. This is intended to deter any negligence that could jeopardize public health and safety.
