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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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SFDA Approves the Registration of Qalsody for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

2025-10-09

The Saudi Food and Drug Authority (SFDA), has approved the registration of Qalsody (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. ALS is a rare motor neuron disorder that progressively affects the nerve cells responsible for voluntary movement, leading to muscle weakness, and eventually, a loss of mobility. This approval reflects the SFDA’s continued efforts to facilitate access to treatments for rare diseases, with Qalsody designated under the Orphan Drug Program.

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SFDA Launches a Dedicated Webpage Highlighting Its Membership in the International Council for Harmonisation (ICH)

2025-10-08

The Saudi Food and Drug Authority (SFDA) has launched a new webpage on its official website dedicated to its membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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Saudi FDA and OIC Organize Workshop on Strengthening Regulatory Systems in Collaboration with WHO

2025-10-01

The Saudi Food and Drug Authority (SFDA), through its educational arm, the SFDA Academy, and the Organization of Islamic Cooperation (OIC), organized a virtual workshop in collaboration with the World Health Organization (WHO). The initiative was aligned with the “Riyadh Declaration” issued during the 3rd Meeting of the Heads of National Medicines Regulatory Authorities (NMRAs) in OIC member states, which emphasized enhancing cooperation and developing regulatory capacities.

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