The Saudi Food and Drug Authority (SFDA) has announced the suspension of a European pharmaceutical factory's registration. This decisive action follows an inspection, part of the SFDA's external monitoring program, which uncovered critical and fundamental violations of Good Manufacturing Practices (GMP). The suspension highlights the SFDA's commitment to safeguarding public health and ensuring the safety and quality of medicines available in Saudi Arabia.

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.