Saudi Arabia has enacted a new Law governing the operations and authority of the Saudi Food and Drug Authority (SFDA). This Law represents a significant development in the legal and institutional architecture of regulatory oversight in the Kingdom, consolidating and enhancing the SFDA’s role in ensuring the safety, quality, and effectiveness of food, drugs, medical devices, and a wide range of health-related products. From a legal standpoint, the Law introduces far-reaching implications for businesses, regulators, and consumers alike, ushering in a new era of accountability, compliance, and governance.
At the heart of the new Law is the formal recognition of the SFDA as a legally independent body, vested with both financial and administrative autonomy. Article 2 of the Law expressly grants the SFDA legal personality, enabling it to act in its own name, contract with third parties, and manage its own budgetary and organisational matters. Importantly, the SFDA reports directly to the President of the Council of Ministers, reinforcing its institutional stature and ensuring that it operates with the authority and independence necessary to fulfil its mission. Headquartered in Riyadh, the SFDA is also empowered to establish regional branches and offices as needed to facilitate nationwide regulatory enforcement.
One of the defining features of the new legislation is the clear articulation of the SFDA’s overarching mandate, as outlined in Article 3. The SFDA’s primary objective is to regulate, monitor, and ensure the safety, quality, and efficacy of food and drug products within its jurisdiction. Its mandate extends beyond human consumption to include animal health, biologicals such as vaccines and serums, cosmetics, health-related products, and medical devices.
The Authority is also responsible for overseeing bottled and non-bottled water, diagnostic and electronic medical equipment, and pesticides used in agriculture and public health. What distinguishes the SFDA’s mandate is its dual commitment to regulatory control and public awareness, ensuring not only that products meet technical standards but also that consumers are informed of their rights and responsibilities in relation to these goods.
The Law is structured around three core functional domains: regulatory, executive, and monitoring duties, each of which is elaborated in Article 5. From a regulatory perspective, the SFDA is empowered to develop policies, frameworks, and standards that govern the entire lifecycle of regulated product, from manufacturing and importation to market clearance and post-market surveillance. It is responsible for setting mandatory specifications for a broad array of items, including food products, health preparations, cosmetics, herbal medicines, laboratory reagents, and medical devices.
The Authority also defines compliance protocols for facilities involved in the manufacture or handling of such products, including food establishments, pharmaceutical plants, water bottling facilities, and pesticide factories. These regulatory functions are to be exercised in coordination with the Ministry of Health and other relevant governmental bodies, ensuring that the SFDA’s work aligns with the broader health infrastructure of the Kingdom.
From an executive standpoint, the SFDA has been granted enforcement authority to implement the Law and its accompanying regulations. This includes conducting laboratory testing and analysis of food, water, drugs, and medical devices to verify their conformity with approved standards. The Authority is also responsible for registering drugs, authorising their circulation in the market, and approving the clearance of imported goods subject to its jurisdiction. It can impose penalties on non-compliant actors, manage emergency responses relating to contaminated or unsafe products, and license private laboratories engaged in testing activities. Notably, the Law authorises the establishment of a central reference laboratory at the SFDA headquarters and specialised branch laboratories across the Kingdom. These institutions will play a vital role in ensuring scientific accuracy, standardisation, and quality assurance.
Another critical aspect of the Law is the SFDA’s monitoring function. The Authority is tasked with supervising the implementation of all relevant licensing procedures, including those for food factories, pharmaceutical companies, and manufacturers of medical devices and pesticides. It must also monitor compliance with Good Manufacturing Practices (GMP) and international safety standards. Inspections of retail markets, warehouses, restaurants, water plants, and herbal shops fall under its purview, often in coordination with municipal and sectoral agencies.
The Authority is further expected to track the quality and authenticity of products in circulation, ensuring that they meet not only the mandatory technical specifications but also the specific manufacturer standards. The inclusion of digital databases, research collaboration with universities, and regional and global partnerships further demonstrate the SFDA’s intent to become a knowledge-based, internationally integrated regulator.
The Law also introduces a number of definitions that serve to eliminate ambiguity and provide legal clarity regarding the scope of the SFDA’s jurisdiction. These definitions cover food, drugs, pesticides, biologicals, cosmetics, water types, medical equipment, and food establishments, among others. The comprehensive nature of these definitions ensures a shared legal understanding among regulated entities, consumers, and enforcement bodies, thereby reducing the risk of misinterpretation or loopholes in enforcement.
From a commercial and legal advisory perspective, the Law significantly impacts how businesses operating in the Kingdom, particularly in the pharmaceutical, healthcare, consumer goods, and food industries, must structure their operations. Companies will need to ensure that their manufacturing practices, importation procedures, advertising protocols, and supply chain systems are fully compliant with the SFDA’s updated requirements. Contracts with suppliers and distributors should be reviewed in light of the SFDA’s expanded enforcement powers, and risk management frameworks should be recalibrated to account for the possibility of regulatory action, including fines, recalls, or suspension of licences.
Moreover, the Law requires businesses to engage more proactively in workforce training and product testing. The SFDA is now mandated to conduct and accredit training programmes for professionals in food and drug-related fields, meaning that compliance is no longer limited to technical product specifications but extends to human capital as well. Businesses may find value in partnering with accredited institutions or investing in internal training infrastructure to remain ahead of regulatory expectations.
The Law of the Saudi Food and Drug Authority represents a landmark development in the Kingdom’s regulatory landscape. It modernises the governance of critical sectors impacting public health and consumer safety, while aligning domestic practices with international benchmarks. For legal practitioners and clients alike, the new Law offers both a challenge and an opportunity, a challenge in navigating enhanced compliance requirements, and an opportunity in shaping safer, more transparent, and more competitive markets. As the SFDA evolves into a more commercially active and scientifically driven authority, we anticipate further implementing regulations to follow, which will provide even greater detail and structure for industry actors to operate within the Kingdom’s legal framework.
We advise all stakeholders to proactively assess the implications of this legislation on their operations and to seek legal counsel where necessary to ensure compliance and readiness for regulatory engagement.