Periodic Safety Update Reports Submission Schedule
2025-07-14
Drugs
Drugs
Report of ADEs Q2- 2025
2025-07-14
report of AEFIs Q2 2025
2025-07-14
The SFDA Approves the Registration of “Winrevair” for the Treatment of Pulmonary Arterial Hypertension under the Orphan Drug Designation Pathway
2025-07-10
The Saudi Food and Drug Authority (SFDA) has approved the registration of Winrevair (Sotatercept), which has been designated as an orphan drug under the SFDA Orphan Drug Program, for the treatment of pulmonary arterial hypertension (PAH) in adult patients classified as WHO Functional Class (FC) II to III, with the aim of improving exercise capacity.
Life-threatening Disease
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Guideline on Quality Considerations for Development and Comparability Assessment of Biosimilars
2025-06-18
SFDA Joins MedDRA Management Committee: The 6th Global Regulatory Body
2025-06-04
In a move that highlights Saudi Arabia’s growing prominence in global pharmaceutical governance, the Saudi Food and Drug Authority (SFDA) has been officially elected to the Management Committee of the Medical Dictionary for Regulatory Activities (MedDRA)— becoming the sixth regulatory authority worldwid
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SFDA GMP Inspection Deficiency Data Trend 2024
2025-06-02
The SFDA Hajj Operations Center Offers Immediate Response to Reports and Maintains Coordination with Government Entities
2025-05-31
Operating around the clock, the Saudi Food and Drug Authority (SFDA), through its Hajj Operations Center, serves as a central point of contact to support field teams and ensure quick responses to reports throughout the Hajj season. This dedication aligns with the Authority's commitment to safeguarding the health and safety of pilgrims, reflecting the generous care extended by our wise leadership towards the pilgrims and their unwavering concern for their comfort and well-being.
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The SFDA CEO Reviews Field Preparedness for Hajj Season
2025-05-29
As part of the Authority's ongoing efforts to ensure the safety and well-being of pilgrims, H.E. Prof. Dr. Hisham S. Aljadhey, Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), conducted a field visit to the SFDA office in Makkah. The visit aimed to assess the implementation of operational plans for the 2025 Hajj season and confirm the readiness of services provided by the Authority to support a safe and healthy pilgrimage.
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SFDA: The World's First Regulator to Use AI for Drug Risk Reduction
2025-05-28
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.