The Saudi FDA is the World's First Regulator to Use AI for Drug Risk Reduction

RIYADH, SAUDI ARABIA, May 28, 2025 /EINPresswire.com/ -- In a pioneering achievement, the Saudi Food and Drug Authority (SFDA) launched in 2023 the world's first regulatory mechanism that leverages artificial intelligence (AI) to actively reduce pharmaceutical risks. This groundbreaking system utilizes an integrated analytical approach to significantly enhance decision-making accuracy, accelerate response times, and enhance the overall efficiency of drug safety within the Kingdom of Saudi Arabia. Critically, it employs deep learning, based on the analysis of real-world data, to select the most appropriate risk reduction plans – a model considered globally innovative.

This qualitative transformation began in 2021 when the SFDA developed a sophisticated technical tool. This tool, powered by advanced AI algorithms, is built upon three analytical pillars: specialist expertise, patient data, and drug characteristics. Together, these elements create a highly accurate predictive model for identifying potential risks associated with drug use.

This marks a profound qualitative shift in global regulatory practices. While most regulatory authorities worldwide typically rely solely on human assessment to choose drug risk reduction plans, the SFDA has expanded its assessment scope to include multiple data sources. This comprehensive approach allows for a far more accurate understanding of the variables that might affect product safety and ensures the selection of the most effective tools based on real-world data.

This innovative AI tool has played a crucial role in accelerating the risk prediction process and increasing the efficiency of decisions related to drug registration, updates, and withdrawals. These decisions are now based on immediately applicable scientific criteria. Furthermore, the SFDA has formed a dedicated national team to develop this system and enhance the capabilities of Saudi personnel in leveraging this smart technology to serve pharmaceutical legislation and control.

This strategic approach is an integral part of a broader strategy led by the SFDA to strengthen the Kingdom's position in food and drug control. It underscores Saudi Arabia's leadership in employing modern technologies to safeguard human health and safety.

Bshayer Al Qahtani
Saudi Food and Drug Authority
+966 50 062 0286
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