Saudi Food and Drug Authority

The Saudi Food and Drug Authority (SFDA) is the entity tasked with overseeing, regulating, and ensuring the safety of food, drugs, and electronic devices, including medical and personal devices that impact the well-being of humans and animals within the Kingdom of Saudi Arabia. Its responsibilities include setting mandatory regulations, laws, and benchmarks, inspecting imported and local products made in laboratories, and educating consumers about them.

The Saudi Food and Drug Authority was established by a Council of Ministers decision in 2003 as an independent entity with a juridical personality. It is responsible for all regulatory, procedural, and executive tasks related to ensuring the safety of food and drugs for humans and animals, in addition to the safety of chemical and biological preparations, and electronic products related to human health. The authority has not undergone any name changes or mergers since its establishment. To execute its tasks, the authority established a long-term strategy that included three strategic plans, the last of which concluded at the end of 2022. Subsequently, it launched the fourth strategy (2023-2027), which represents a continuation of the authority's work.

The Saudi Food and Drug Authority was established to undertake the tasks of monitoring, regulating, and supervising food and drugs, alongside medical devices, and their standard specifications. It is tasked with conducting inspections and monitoring both its own laboratories and those of other entities, and raising consumer awareness within its jurisdiction. Its objectives include ensuring the safety of biological and chemical supplements, cosmetics, and pesticides, safeguarding electronic products from adverse health effects, setting precise standards for medical and diagnostic devices and their safety, as well as developing policies and procedures related to food and drugs, and planning their implementation and activation.

The authority also aims to conduct research and studies that contribute to understanding health problems and their causes, determining their effects, and establishing a scientific basis for use in advisory services and implementation programs in the fields of food and drugs. Additionally, it oversees the licensing processes for food and drug manufacturing facilities and medical device factories, monitors them, exchanges information with specialized scientific bodies and local and global legal entities, and establishes a database about food and drugs.

The Saudi Food and Drug Authority performs its duties in accordance with regulations and laws that guide its operations and contribute to achieving its goals. Since its establishment, it has issued a number of regulations and laws, starting with the Law of the Saudi Food and Drug Authority issued in 2007, which includes twenty-five articles covering the authority's regulatory, executive, and supervisory tasks. Additionally, there are regulations related to the food sector, including the Food Hygiene Requirements, which clarify the obligations of food facility operators and the hygiene requirements for these operators. In the pharmaceutical sector, regulations include Food Clearance Conditions and Requirements and Pricing Rules for Pharmaceutical Products. There are also several regulations related to the medical devices sector, including the Law of Medical Devices and Supplies issued in 2021.

The authority also issued a system that includes the conditions for the clearance of feed products, and a quality guide for laboratories, and, in the field of cosmetics, it enacted several regulations, including: Guidance and Requirements of Cosmetic product Notification, and conditions for the clearance of cosmetic products and the raw materials involved in their manufacture.

The Saudi Food and Drug Authority plays several roles in ensuring the safety and security of food for both humans and animals, as well as the safety of pesticides. It formulates food safety policies, plans for their implementation, and undertakes tasks to achieve its objectives. These tasks include: developing legislation encompassing food specifications and technical regulations to serve the Kingdom's interests and meet the requirements of World Trade Organization agreements; contributing locally, regionally, and internationally to the preparation and review of food specification projects; participating in the development of policies and regulations related to healthy food; investigating foodborne diseases; and designing national programs and plans to monitor food and feed contaminants.

In addition to its food-related tasks, the authority's responsibilities include: assessing chemical, physical, microbial, and health risks based on scientific principles; acting as the Kingdom's accredited contact point in the Codex Alimentarius Commission; monitoring and managing food-related notifications and alerts; developing alert procedures for pesticides and feeds; evaluating the toxicity of tobacco product contents and preparing safety reports; preparing specifications and regulations for tobacco products; and representing the Kingdom in relevant national, regional, and international technical committees' meetings.

The authority assumes a regulatory role in overseeing food safety and security. It evaluates food products to ensure their safety before and after they are marketed. Additionally, it scientifically evaluates pesticides and feed products, supporting procedures related to their registration and licensing. It also assesses food advertisements and evaluates food safety training programs, endorsing them. Furthermore, it oversees the imposition and lifting of bans on food products and supervises the Center for Notification of Sanitary and Phytosanitary Measures (SPS).

The authority, in collaboration with the Ministry of Municipal and Rural Affairs and Housing and the Ministry of Environment, Water, and Agriculture, has developed the National Food Monitoring and Surveillance Program. This program aims to assess the safety of food throughout the food chain, ensuring consumer health protection from any potential harm resulting from the consumption of local and imported food products. It measures the extent to which these products comply with standard specifications and executive regulations.

The Saudi Food and Drug Authority collaborates with representatives from several ministries, including the Ministries of Interior, Commerce, Municipal and Rural Affairs and Housing, Finance, Health, Education, Economy and Planning, Environment, Water, and Agriculture, Energy, and Industry and Mineral Resources. Additionally, it collaborates with the Saudi Standards, Metrology, and Quality Organization, among other relevant entities. Often, it conducts regulatory inspections and surveillance patrols.

As of 2022, the Saudi Food and Drug Authority had approximately 2,166 male and female employees and operated twenty-nine branches spread across six provinces. Additionally, the authority has six laboratories located in six out of the thirteen administrative provinces of the Kingdom.

The activity of the Saudi Food and Drug Authority includes four main sectors:

Food: Through this sector, the authority aims to ensure the safety of food for humans and animals, as well as the safety and security of pesticides. It also strives to facilitate trade while ensuring food safety. Additionally, it works on enhancing consumer and stakeholder confidence in the regulatory system.

Drugs: The Saudi Food and Drug Authority works to ensure the safety, efficacy, quality, and licensing of the marketing of medications. This includes verifying the safety of medicinal plants, health supplements, and herbal products, as well as the quality of drugs available on the market. The authority also monitors drugs post-marketing and checks the safety of cosmetic products.

Medical Devices: the Saudi Food and Drug Authority seeks to regulate the rules and procedures for the registration of medical devices and products, establishing mechanisms tailored to the specific tasks associated with this field, and ensuring device safety, quality, and effectiveness.

Laboratories: The Saudi Food and Drug Authority works to analyze and monitor drugs (imported or manufactured within the Kingdom), whether human or veterinary, as well as health and herb preparations, biopharmaceuticals, and cosmetics, through the National Drug and Cosmetics Control Laboratory, which is the official control laboratory in the Kingdom.

The operations sector of the authority works across several departments, handling the executive and regulatory procedures of the authority. It oversees the registration of licenses for establishments and products within the authority’s scope and monitors compliance by organizing visits and inspection tours to ensure that products on the market are appropriate. Additionally, the operations sector conducts electronic surveys of imported products and coordinates with governmental bodies on joint tasks. It works on issuing classification guides, categorizing new products, and enhancing the efficiency of local market surveillance.

The Saudi Food and Drug Authority, through its various sectors, holds memberships in a number of international organizations, including:

• The International Council for Harmonisation (ICH)

• International Pharmaceutical Regulators Program (IPRP)

• International Coalition of Medicines Regulatory Authorities (ICMRA)

• International Organization for Standardization (ISO)

• GCC Standardization Organization (GSO)

• International Regulatory Cooperation for Herbal Medicines (IRCH)

• The Standards and Metrology Institute for the Islamic Countries (SMIIC)

• International Cooperation on Cosmetics Regulation (ICCR)

• International Medication Safety Network (IMSN)

• International Council for Harmonisation of Veterinary Products

• International Organization for Standardization (ISO)

• International Pharmaceutical Regulators Programme (IPRP)

GCC Standardization Organization (GSO)

The Saudi Food and Drug Authority receives inquiries and reports in both Arabic and English through its unified call center at the number (19999). The center handles calls related to the areas of food, drugs, products, medical devices, and cosmetic preparations, as well as feed and pesticides. It provides information about alerts and warnings issued by the authority, in addition to food products regulated by the authority, bottled drinking water, and registered medical, herbal, and cosmetic preparations, including their availability and prices. Additionally, it offers the possibility to inquire about the authority's programs, activities, and events.

Callers can report cases where any food product is sold with medical claims, any unlisted cosmetic preparations, or food products sold with medical claims typically associated with herbal remedies. They can also report any noticeable defects in the quality of a drug or cosmetic product or an unpleasant taste in bottled drinking water. Additionally, reports can be made about any cosmetic product or drug that has been warned against, improper storage of medications, storage of medical devices in non-compliant warehouses, or the use of unregistered medical devices by a healthcare facility.