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

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

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.

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.

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.

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Itovebi (Inavolisib( developed by Roche. The investigational therapy is intended for use in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine therapy.

As part of its comprehensive preparations for the Hajj season 2025, the Saudi Food and Drug Authority (SFDA) has intensified its proactive inspection efforts, conducting over 1,329 field visits to food, pharmaceutical, and medical device warehouses in the Makkah and Madinah regions. This aligns with the remarkable compliance rates observed in facilities storing food and medicine, a direct result of ongoing inspections and awareness-raising efforts that have reinforced their commitment to the requirements.