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The SFDA Approves Clinical Trial for Novel Biologic Therapy for Genetic Propionic Acidemia

2025-05-04

Experimental Treatment by mRNA

The Saudi Food and Drug Authority (SFDA) has approved a clinical study registration titled "A Global Phase 1/2 Open-Label Dose-Optimization Study to Evaluate the Safety and Pharmacokinetics of the Biologic Treatment (mRNA-3927) in Participants with Propionic Acidemia." This research will investigate an innovative experimental therapy utilizing messenger RNA (mRNA) technology to address a rare inherited disorder affecting amino acid metabolism.

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Classifying Legal Status of Veterinary Medicinal Products Guidance

2025-05-04
Classifying Legal Status of Veterinary Medicinal Products Guidance
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The SFDA: Leveraging Modern Technology for Enhanced Hajj Inspection Efficiency

2025-05-03

The Saudi Food and Drug Authority (SFDA) is continuously advancing its regulatory framework and boosting its operational effectiveness. This aligns with the Health Sector Transformation Program, a key pillar of Saudi Vision 2030.

During the Hajj season, the SFDA intensifies its focus on employing technologies to protect pilgrim health and safety by providing top-tier quality control and regulatory services that meet the highest standards.

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Drug Factory License

It is a service that is provided to grant a license to pharmaceutical factory facilities

Service steps

  • Log in to the Ghad Platform.
  • Create an account based on user type.
  • Submit a facility registration application.
  • Pay the fee.
  • Issue the license after approval and review.

Conditions

Active account on the Ghad platform, and environmental permit from the National Center for Environmental Compliance Control

Service requirements

  • A commercial register includes the economic activity related to SFDA's activities.
  • An industrial License.
  • Academic certificates, experience, and professional registration cards for the technical manager and quality control officer. 

Frequently asked questions

- كيف يمكنني الحصول على الرخصة؟

بإمكانكم الحصول على الترخيص من خلال النظام الموحد - غد -

- هل للرخصة تاريخ انتهاء؟

نعم. بحسب ما تم تقديمه وتوضيحه أثناء تقديم طلب الترخيص.

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SFDA Clears the First Medical Shipment of 44 Tons for Hajj Pilgrims

2025-04-26

The Saudi Food and Drug Authority (SFDA) has successfully completed the clearance procedures for the first medical shipment intended for this year's Hajj pilgrims. The shipment arrived via Prince Mohammed bin Abdulaziz International Airport in Medina, weighing 44 tons and consisting of essential medicines and medical products.

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The SFDA and ANSES (France) Partner on Veterinary Medicines via MoU

2025-04-24

The Saudi Food and Drug Authority (SFDA) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) have signed a Memorandum of Understanding (MoU) focused on the management of veterinary medicinal products. The agreement aims to strengthen collaboration and facilitate the exchange of information and expertise between the two parties.

The signing took place in Paris, France, during the official visit of H.E. Mr. Fahad Abdulrahman AlJalajel, the Minister of Health of Saudi Arabia and Chairman of the SFDA Board of Directors.

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The SFDA Organizes Drug Innovation Conference

2025-04-22

The Saudi Food and Drug Authority (SFDA) hosted the Drug Innovation Conference, timed to coincide with World Creativity and Innovation Day. The event, held at the SFDA's headquarters in Riyadh, drew participation from officials representing government authorities, research centers, and universities.

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SFDA: The SFDA Confirms its Preparedness to Ensure Products Safety Throughout the 2025 Hajj Season

2025-04-19

The Saudi Food and Drug Authority (SFDA) has announced the readiness of its personnel for the 2025 Hajj season (1446 AH), dedicated to ensuring the safety of food, medicine, and medical devices supplied to pilgrims, aligning with a comprehensive plan developed by the Authority for this occasion. 

This undertaking reflects the unwavering commitment of the wise leadership to serve pilgrims and dedicate all resources to their comfort and well-being, upholding the tradition established by the leaders of our blessed nation.

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SFDA GCP Trend analysis 2024

2025-03-16
SFDA GCP Trend analysis 2024
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