Latest news with #SaudiFoodandDrugAuthority
Gulf Insider
16 hours ago
- Health
- Gulf Insider
Saudi Arabia: SFDA Shuts Frozen Food Factory, Halts Production Lines Over Serious Violations
The Saudi Food and Drug Authority (SFDA) has shut down a frozen ready-to-eat food factory and suspended production lines at several other facilities after uncovering serious health violations that posed direct risks to consumer safety. The enforcement actions followed inspection campaigns carried out last month as part of SFDA's proactive monitoring program to ensure compliance with national food safety standards and prevent potential foodborne illnesses. In one facility producing pickles and ready meals, inspectors found poor hygiene, unsafe operating practices, and ineffective safety supervision — conditions conducive to the growth of harmful pathogens such as Listeria monocytogenes, E. coli, and Salmonella spp., all of which can cause acute food poisoning. Although the facility was given a deadline to correct the violations under Article 12 of the Food Law (Royal Decree No. M/38, dated 28/4/1440H), it failed to comply within the required timeframe. This led to the full suspension of its production lines and the initiation of legal proceedings. In a separate case, violations were detected at another facility producing ready-to-eat poultry products. These included employing unlicensed workers, lacking a valid HACCP food safety certification, storing expired food without clear separation, and using corroded, unsafe food-contact equipment. The SFDA imposed fines under Article 20 of the Food Law's executive regulations and partially suspended the facility's operations until corrective measures are taken. Additionally, the authority suspended 11 production lines across several dairy and frozen pastry plants after lab tests confirmed contamination with Clostridium perfringens, a common cause of foodborne illness. All facilities were instructed to implement corrective action plans within 30 days, including upgrading quality systems, retraining staff, and replacing non-compliant equipment. Follow-up inspections will ensure compliance. The SFDA emphasized that these actions reflect its commitment to preventive public health protection and are supported by legal provisions allowing stringent measures, including suspension, imprisonment, or fines up to SR10 million. The authority urged consumers to report any suspected food violations via the unified hotline (19999), affirming that food safety is a shared responsibility from production to the dining table.
Saudi Gazette
2 days ago
- Health
- Saudi Gazette
SFDA shuts frozen food factory, halts production lines over serious violations
Saudi Gazette report RIYADH — The Saudi Food and Drug Authority (SFDA) has shut down a frozen ready-to-eat food factory and suspended production lines at several other facilities after uncovering serious health violations that posed direct risks to consumer safety. The enforcement actions followed inspection campaigns carried out last month as part of SFDA's proactive monitoring program to ensure compliance with national food safety standards and prevent potential foodborne illnesses. In one facility producing pickles and ready meals, inspectors found poor hygiene, unsafe operating practices, and ineffective safety supervision — conditions conducive to the growth of harmful pathogens such as Listeria monocytogenes, E. coli, and Salmonella spp., all of which can cause acute food poisoning. Although the facility was given a deadline to correct the violations under Article 12 of the Food Law (Royal Decree No. M/38, dated 28/4/1440H), it failed to comply within the required timeframe. This led to the full suspension of its production lines and the initiation of legal proceedings. In a separate case, violations were detected at another facility producing ready-to-eat poultry products. These included employing unlicensed workers, lacking a valid HACCP food safety certification, storing expired food without clear separation, and using corroded, unsafe food-contact equipment. The SFDA imposed fines under Article 20 of the Food Law's executive regulations and partially suspended the facility's operations until corrective measures are taken. Additionally, the authority suspended 11 production lines across several dairy and frozen pastry plants after lab tests confirmed contamination with Clostridium perfringens, a common cause of foodborne illness. All facilities were instructed to implement corrective action plans within 30 days, including upgrading quality systems, retraining staff, and replacing non-compliant equipment. Follow-up inspections will ensure compliance. The SFDA emphasized that these actions reflect its commitment to preventive public health protection and are supported by legal provisions allowing stringent measures, including suspension, imprisonment, or fines up to SR10 million. The authority urged consumers to report any suspected food violations via the unified hotline (19999), affirming that food safety is a shared responsibility from production to the dining table.
See - Sada Elbalad
2 days ago
- Health
- See - Sada Elbalad
Saudi Arabia Approves First Alzheimer's Treatment
Israa Farhan Saudi Arabia has approved its first-ever treatment for Alzheimer's disease, marking a major step forward in the kingdom's efforts to expand cutting-edge healthcare. The Saudi Food and Drug Authority (SFDA) announced on Tuesday the registration of the drug Leqembi (Lecanemab), a pioneering biologic therapy administered via intravenous infusion every two weeks. The medication is designed for patients in the early stages of Alzheimer's, including those with mild cognitive impairment or early dementia. It specifically targets individuals who carry no more than one copy of the ApoE4 gene variant, which is associated with increased Alzheimer's risk. According to the SFDA, Leqembi belongs to a new class of innovative biologic drugs developed using monoclonal antibody technology. The treatment works by targeting beta-amyloid proteins that build up in the brain, helping to slow the formation of plaques known to be linked to cognitive decline in Alzheimer's patients. The approval followed a thorough evaluation of the drug's efficacy, safety, and quality. Clinical trials have shown promising results, indicating that the treatment can slow disease progression compared to a placebo, based on standard clinical measures used to assess Alzheimer's treatments. Common side effects reported include headaches, infusion-related symptoms, and changes detectable by MRI scans known as Amyloid-Related Imaging Abnormalities (ARIA), which may involve brain swelling or microbleeds. These effects are associated with the drug's mechanism and are closely monitored during treatment. The SFDA stressed the importance of regular monitoring throughout the treatment period, especially to track potential side effects. It also highlighted the need for genetic screening before starting the therapy to reduce the risk of adverse reactions. As part of the approval conditions, the pharmaceutical company is required to submit ongoing safety and efficacy reports and implement a robust risk management plan to ensure safe and effective use of the drug. read more Gold prices rise, 21 Karat at EGP 3685 NATO's Role in Israeli-Palestinian Conflict US Expresses 'Strong Opposition' to New Turkish Military Operation in Syria Shoukry Meets Director-General of FAO Lavrov: confrontation bet. nuclear powers must be avoided News Iran Summons French Ambassador over Foreign Minister Remarks News Aboul Gheit Condemns Israeli Escalation in West Bank News Greek PM: Athens Plays Key Role in Improving Energy Security in Region News One Person Injured in Explosion at Ukrainian Embassy in Madrid News Israeli-Linked Hadassah Clinic in Moscow Treats Wounded Iranian IRGC Fighters Arts & Culture "Jurassic World Rebirth" Gets Streaming Date News China Launches Largest Ever Aircraft Carrier News Ayat Khaddoura's Final Video Captures Bombardment of Beit Lahia Videos & Features Tragedy Overshadows MC Alger Championship Celebration: One Fan Dead, 11 Injured After Stadium Fall Business Egyptian Pound Undervalued by 30%, Says Goldman Sachs Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt Arts & Culture South Korean Actress Kang Seo-ha Dies at 31 after Cancer Battle Arts & Culture Lebanese Media: Fayrouz Collapses after Death of Ziad Rahbani Sports Get to Know 2025 WWE Evolution Results
Time of India
3 days ago
- Health
- Time of India
What is Leqembi? The first Alzheimer's treatment approved today in Saudi Arabia
Leqembi targets beta-amyloid plaques in the brain, aiming to slow Alzheimer's progression in patients with mild cognitive impairment The Saudi Food and Drug Authority (SFDA) announced today the official approval of Leqembi, the first Alzheimer's treatment available in Saudi Arabia. This approval marks a significant milestone in addressing Alzheimer's, a progressive brain disorder that affects memory and thinking skills. Leqembi is specifically indicated for patients experiencing mild cognitive impairment or mild dementia caused by Alzheimer's, who have either no copies or just one copy of a particular gene variant known as apolipoprotein E4 (ApoE4). How Leqembi Works: Targeting the Root Cause Leqembi represents an innovative approach to treating Alzheimer's. Unlike many existing therapies that only ease symptoms, this drug aims to slow the actual progression of the disease. It is a biologic therapy developed using monoclonal antibody technology, a sophisticated method that creates lab-produced molecules designed to target specific proteins in the body. In this case, Leqembi works by targeting beta-amyloid proteins, which tend to build up in the brains of Alzheimer's patients and form sticky clumps called plaques. These plaques are widely believed to contribute to the cognitive decline seen in the disease. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Patrocinio: Unsold Furniture Liquidation 2024 (Prices May Surprise You) Unsold Furniture | Search Ads Learn More Undo Specifically, brain plaques, known as amyloid plaques, are abnormal clumps of protein fragments called beta-amyloid that build up in the brain, especially in people with Alzheimer's. These plaques interfere with the normal communication between nerve cells (neurons), disrupting brain function. By helping reduce the formation of these harmful plaques, Leqembi seeks to protect brain function and slow cognitive decline over time. The treatment is given through an intravenous infusion every two weeks, allowing the drug to circulate and act within the brain. Proven Effectiveness Backed by Clinical Studies Before approving Leqembi, the SFDA thoroughly reviewed evidence of its safety, effectiveness, quality, and compliance with regulatory standards. Clinical trials revealed that Leqembi significantly slows the progression of Alzheimer's disease compared to a placebo. The effectiveness was measured using established clinical scales that assess memory, thinking, and daily functioning abilities. However, like all medications, Leqembi can cause side effects. The most commonly reported include: Headaches Reactions related to the infusion process Amyloid-related imaging abnormalities (ARIA), a term that refers to unusual changes detected in brain MRI scans. These abnormalities may include swelling (cerebral edema) or tiny brain bleeds (microhemorrhages). Because ARIA can only be detected through brain scans, careful monitoring is essential throughout treatment. Safety First: The Need for Careful Patient Monitoring The SFDA stresses the importance of ongoing patient monitoring during treatment. Before starting Leqembi, patients must be tested for their ApoE4 gene status, as this influences the risk of side effects. Those with two copies of the ApoE4 gene are not currently eligible for the treatment due to a higher likelihood of complications. Additionally, the pharmaceutical company responsible for Leqembi is required to track how the drug performs once it is in use (post-marketing surveillance). They must regularly submit updated reports on safety and effectiveness to the SFDA. A comprehensive risk management plan is also mandatory to ensure the treatment is used safely and responsibly. Advancing Healthcare with Biotechnology in Saudi Arabia The approval of Leqembi reflects the SFDA's commitment to expanding access to advanced and high-quality medical treatments, especially those developed through cutting-edge biotechnological methods. Biotech therapies like Leqembi represent a rapidly growing field in medicine, offering new hope for diseases that previously had limited treatment options. About the SFDA Established in 2003 under the Council of Ministers' resolution, the Saudi Food and Drug Authority is an independent regulatory body directly reporting to the President of the Council of Ministers. Its main mission is to safeguard public health by ensuring the safety and quality of food, medicines, biological and chemical substances, medical devices, and cosmetics. The SFDA oversees all procedures related to these products, aiming to protect both human and animal health throughout the Kingdom.
Saudi Gazette
3 days ago
- Health
- Saudi Gazette
Saudi Arabia approves first Alzheimer's treatment with lecanemab for early-stage patients
Saudi Gazette report RIYADH — The Saudi Food and Drug Authority (SFDA) has officially approved the registration of lecanemab (Leqembi) for the treatment of patients with early-stage Alzheimer's disease, specifically those with mild cognitive impairment or mild dementia, who carry no copies or just one copy of the ApoE4 gene variant. This marks the first approved Alzheimer's treatment in the Kingdom. In a statement, the SFDA noted that lecanemab is a biologic drug based on monoclonal antibody technology, and is the first biologic therapy licensed for Alzheimer's in Saudi Arabia. The treatment works by targeting amyloid beta protein plaques in the brain, a hallmark of Alzheimer's pathology, thereby helping slow cognitive decline. The drug is administered via intravenous infusion every two weeks. The authority said the approval followed a comprehensive evaluation of the drug's efficacy, safety, and quality, with clinical trials showing that lecanemab slows the progression of symptoms compared to placebo, based on established Alzheimer's disease assessment scales. The most commonly reported side effects included headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA) — brain changes detectable via MRI that may involve brain swelling or microbleeds. The SFDA emphasized the importance of ongoing patient monitoring during treatment, particularly for any emerging side effects. Genetic testing is required before initiating therapy to assess patient eligibility and reduce risk of adverse reactions. The authority also required the manufacturer to submit regular post-marketing reports on the drug's effectiveness and safety, and to implement a risk management plan to ensure the treatment's optimal and safe use.
