The Saudi Food and Drug Authority (SFDA) has approved the first gene therapy for Hemophilia (B) in the Kingdom of Saudi Arabia. It has announced the registration of Hemgenix (etranacogene dezaparvovec) for use in patients with moderate to severe Hemophilia (B), a life-threatening genetic disorder. This condition is caused by a defect in the gene responsible for producing clotting factor IX, a protein essential for effective blood clotting and stopping bleeding.

The Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, contributed his insights to a prominent panel discussion on “Regulatory Pathways: Balancing Innovation and Safety” at the Global Healthspan Summit 2025 in Riyadh on Tuesday. The session centered on the pivotal role of regulatory frameworks in fostering innovation while ensuring public safety, particularly in efforts to extend healthy lifespans.

The Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, conducted an inspection visit to several facilities in Jeddah, including the Authority's branch office in the Western Region. This visit aimed to monitor operational progress and ensure the effectiveness of services to safeguard product safety. It is part of a series of routine tours across the Kingdom of Saudi Arabia to enhance oversight of products under the SFDA's jurisdiction.

The Saudi Food and Drug Authority (SFDA) advises that ginseng (scientifically known as Panax Ginseng), used in alternative medicine as a general tonic to enhance energy levels and mitigate stress, should be used with caution. High-dose consumption may result in side effects such as insomnia and high blood pressure. Furthermore, pregnant and lactating women are advised to avoid ginseng due to a lack of safety data.

The Saudi Food and Drug Authority (SFDA) has achieved a landmark milestone by becoming the first organization in the Middle East to be elected to the Management Committee of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), joining seven international counterparts and eight representatives from global organizations.

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), recently conducted an inspection tour of the Authority’s Eastern Province branch, visiting several affiliated facilities.