Skip to main content

The SFDA Begins Field Inspection Tours as Part of the Hajj Season Preparations

2025-05-15

As part of its early and comprehensive preparations for the Hajj season 2025, the Saudi Food and Drug Authority (SFDA) has launched a series of field inspection tours across key locations and facilities. The purpose is to assess the state of readiness of the inspection teams and to monitor the implementation of approved plans, with the aim of protecting the health and safety of pilgrims by ensuring the highest standards of food, drug, and medical product safety.

Other News

The Implementing Regulations of the Law of Pharmaceutical and Herbal Establishments and Products

2020-12-28
The Implementing Regulations of the Law of Pharmaceutical and Herbal Establishments and Products
List
Has the page content helped you?

The SFDA Grants Breakthrough Designation to Atrasentan (Vanrafia) for Primary Immunoglobulin A (IgA) Nephropathy

2025-05-13

Treatment

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Novartis's medication Atrasentan (Vanrafia) , which is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

A Selective Endothelin (A) Receptor Antagonist

Other News

Regulatory Guidance for Literature Based Support for Efficacy and Safety of Medicine

2025-05-12
Regulatory Guidance for Literature Based Support for Efficacy and Safety of Medicine
Guide
Has the page content helped you?

The SFDA Grants Breakthrough Designation to Qfitlia for Hemophilia A and B

2025-05-10

The Saudi Food and Drug Authority (SFDA) has granted breakthrough designation to Sanofi's medication, Fitusiran (Qfitlia), which is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and adolescent patients aged 12 years and older with hemophilia A or B, with or without factor VIII or IX inhibitors.

Other News

The SFDA Approves Breakthrough Designation Application for Breast Cancer Therapy “Inluriyo”

2025-05-05

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Eli Lilly’s medication, Imlunestrant (Inluriyo), for the treatment of advanced breast cancer. Imlunestrant is being developed as a monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously been treated with an endocrine based regimen.

Imlunestrant: A Selective Estrogen Receptor Inhibitor

Other News

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.

Other News

Classifying Legal Status of Veterinary Medicinal Products Guidance

2025-05-04
Classifying Legal Status of Veterinary Medicinal Products Guidance
Guide
Has the page content helped you?

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.

Other News

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.

Has the page content helped you?
Subscribe to Drugs