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SFDA Approves the Registration of “Pemazyre” for the Treatment of Bile Duct Cancer in Adults

2025-11-10

The Saudi Food and Drug Authority (SFDA) has approved the registration of Pemazyre (Pemigatinib) as a monotherapy for adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, who have progressed after at least one prior line of systemic therapy.

Inhibition of Signals that Stimulate Cancer Cell Growth

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SFDA CEO Launches National Network for Drugs and Medical Products Safety During Pregnancy and Breastfeeding

2025-10-30

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched the National Network for Drugs and Medical Products Safety During Pregnancy and Breastfeeding on the sidelines of the SFDA's participation in the Global Health Exhibition. The Exhibition was held in Riyadh from October 27–30, with the participation of more than 2,000 entities from around the world.

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SFDA CEO Launches “RASID” Smart Service for Verifying Controlled Medications Carried by Visitors to Saudi Arabia

2025-10-30

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched the Regulatory AI System for Incoming Drugs (RASID) smart service, which utilizes artificial intelligence technologies to regulate and control the entry of controlled medications carried by travelers. The launch took place during the Global Health Exhibition, held from October 27 to 30 at the Riyadh International Convention and Exhibition Center in Malham. 

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Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Clinical Trial Application

2025-10-30
Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Clinical Trial Application
Guide
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SFDA CEO Launches an AI Model to Proactively Predict Drug Shortages in Saudi Arabia

2025-10-29

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched an AI-powered model for predicting drug shortages in the Kingdom of Saudi Arabia. The launch took place during the Global Health Exhibition, held from October 27 to 30. It highlights the SFDA's commitment to enhance drug monitoring and proactively address any potential shortages.

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SFDA CEO Launches the Saudi Pharmacopoeia on the Sidelines of the Global Health Exhibition

2025-10-27

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, launched the “Saudi Pharmacopoeia” on the sidelines of the SFDA's participation in the Global Health Exhibition (GHE) held at the Riyadh Exhibition and Convention Center in Malham from October 27 to 30, under the theme “Invest in Health.”

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First from the Middle East and North Africa: ICMRA Announces Saudi Arabia as a Full Member

2025-10-26

The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the full membership of the Kingdom of Saudi Arabia, represented by the Saudi Food and Drug Authority (SFDA). This achievement makes the SFDA the first regulatory authority from the Middle East and North Africa (MENA) to become full member in ICMRA.

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Verification and Abridged Pathways

2025-10-20
Verification and Abridged Pathways
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The SFDA CEO Meets with Pharmaceutical Companies to Strengthen Investor Support

2025-10-14

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), met at the Authority’s headquarters in Riyadh with several chief executives and representatives of local and international pharmaceutical companies to discuss key issues and opportunities that will contribute to the growth and support of the pharmaceutical sector in the Kingdom.

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Report of ADEs Q3- 2025

2025-10-13
Report of ADEs Q3- 2025
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