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SFDA Approves Registration of New Treatment for Advanced or Metastatic Breast Cancer with a Gene Mutation

2026-05-15

The Saudi Food and Drug Authority (SFDA) has approved the registration of Etcamah (camizestrant) for the treatment of adult patients with locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with an ESR1 gene mutation that emerges during first-line hormonal therapy, in combination with CDK4/6 inhibitors.

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SFDA CEO Inspects Hajj Preparedness Across Facilities and Operational Sites in the Makkah and Eastern Regions

2026-05-08

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), conducted a field inspection tour of several SFDA facilities and operational sites in the Makkah and Eastern Regions as part of the intensive preparations for this year’s Hajj season. The tour aimed to enhance the efficiency of regulatory procedures and ensure the safety of incoming products, contributing to safeguarding the health and safety of pilgrims.

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SFDA Certified Regulations for Pilgrims Carrying Controlled Medications

2026-05-05

The Saudi Food and Drug Authority (SFDA) has clarified the approved regulations and procedures for obtaining personal clearance permits for medications containing narcotic drugs or psychotropic substances carried by pilgrims for personal use. This initiative is part of the Authority’s ongoing efforts to serve the Guests of Allah, facilitate the performance of their rituals, and ensure the safety and well-being of all visitors to the Holy Sites.

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SFDA Completes Comprehensive Preparations to Ensure Pilgrim Safety for Hajj 1447 AH

2026-04-30

The Saudi Food and Drug Authority (SFDA) has finalized its comprehensive, integrated operational plan for the Hajj season 1447 AH (2026). This readiness aligns with the directives of the Kingdom of Saudi Arabia’s wise leadership to prioritize the health and well-being of pilgrims, leveraging all available resources to ensure a safe and seamless Hajj journey. These efforts underscore the Kingdom’s longstanding commitment to the service and care of the Two Holy Mosques and their visitors.

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Framework on the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to Support Effectiveness and Safety for Marketing Authorization of Medicinal Products

2026-04-20
Framework on the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to Support Effectiveness and Safety for Marketing Authorization of Medicinal Products
Guide
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Guideline on good pharmacovigilance practices(GVP)Product- or Population-Specific Considerations III: Advanced Therapy Medicinal Products

2026-04-12
Guideline on good pharmacovigilance practices(GVP)Product- or Population-Specific Considerations III: Advanced Therapy Medicinal Products
Guide
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Research and Investigational Drugs (RAID) Designation

2026-04-02
Research and Investigational Drugs (RAID) Designation
Guide
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SFDA GCP Trend Analysis 2025

2026-03-30
SFDA GCP Trend Analysis 2025
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Medicines and Medical Devices Inventory Form Related to the Hajj Campaign

2026-03-30
Medicines and Medical Devices Inventory Form Related to the Hajj Campaign
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SFDA GMP Inspection Deficiency Data Trend 2025

2026-03-12
SFDA GMP Inspection Deficiency Data Trend 2025
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