المملكة: A digital platform and a clinical inspection .. “Food and Drug” enhances innovation with 3 tracks

The Food and Drug Authority continues to enhance innovation in the Kingdom’s health care sector through a series of organizational and technical initiatives that include the development of clinical studies, the evaluation of genetic and cellular treatments, and the adoption of innovative medical devices.
These efforts aim to facilitate the access of patients to advanced medical techniques, and to consolidate the Kingdom’s position as a regional center for research and innovation, in line with the targets of Saudi Vision 2030, where the authority works to develop an integrated electronic system to automate clinical studies, in a way that contributes to raising efficiency and improving the user experience, by linking the system to national parties such as the National Institute for Health Research and the National Committee for Biological Ethics.
Speaking of support for research resettlement, the authority signed memoranda of understanding with a number of hospitals and research centers, which led to a 40% increase in the number of clinical studies during the year 2024.

Clinical studies sites

“Food and Drug” also conduct inspection visits to clinical studies sites, biological equivalence centers, and follow -up facilities, with the aim of ensuring adherence to the standards of good clinical documentation practices.

In its endeavor to enhance the research culture, the authority launched specialized training programs targeting researchers and health practitioners, and since 2020, the Kingdom has witnessed remarkable growth in the field of genetic and cellular treatment research, where 10 clinical studies have been approved, which included leading treatments such as Zolgensma to treat spinal muscles, and Casgevy to treat sickle cell anemia, in addition to the Kingdom’s participation in an experiment Hemgenix for hemophilia treatment B.
By the end of 2024, about 149 clinical studies were adopted for medical devices, which included various techniques, including cultivating devices, and digital technologies backed by artificial intelligence.

Health care sector

Among the most prominent of these innovations are: Dose Check application for diabetes management, INOVA tool to diagnose diabetic retinopathy, and Cardio-ESELFIE to monitor vital signs remotely.
The authority is working to enhance its organizational integration through regional and international partnerships, including cooperation with the Gulf Health Council, the International Council for the Unified Organization for Medicines “ICH” and the European Pharmaceutical Agency “EMA”, as well as agreements with a number of leading Saudi bodies.
It also plans to launch an electronic national record for clinical studies during the coming period, which contributes to the development of research infrastructure and support the Kingdom’s aspirations in the health care sector.