The Saudi Food and Drug Authority (SFDA) is responsible for regulating the life science industries in Saudi Arabia, ensuring that products meet stringent standards of safety, efficacy, and quality. The range of regulated products includes pharmaceuticals, biotechnology, medical devices, herbal products, nutraceuticals, cosmetics, food and supplements, as well as veterinary and animal health items.

All companies seeking to market these products in Saudi Arabia must complete SFDA registration. Upon successful review, the company receives an SFDA certificate confirming the product’s approval status.

In this post, we will clarify:

• How to register your products
• Who can apply
• What the SFDA registration requirements are
• How PharmaKnowl can assist you

About the SFDA

The Saudi Food and Drug Authority (SFDA) oversees human and animal products to safeguard the public from harmful, substandard, falsely advertised, counterfeit, or ineffective products. Its core mandate is to ensure product safety, efficacy, and quality.

Among regulatory bodies in the MENA region, the SFDA stands out as the most stringent due to ongoing advancements in Saudi pharmaceutical laws and the growing expertise of local scientists since its inception in 2004. This progress reached a significant milestone in 2021 when the SFDA became a full regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Furthermore, the SFDA achieved WHO Maturity Level 4, an acknowledgement reserved for national regulatory authorities that demonstrate a high level of regulatory performance and a commitment to continuous improvement.

As a result, many Gulf Cooperation Council (GCC) and MENA countries consider Saudi Arabia a key reference country.

SFDA Regulations

The SFDA oversees three primary industries: food, pharmaceuticals (drugs), and medical devices. Beyond these core areas, it regulates other healthcare products such as herbal products, food supplements, cosmetics, biocides, medical supplies, pesticides, and animal health products (including veterinary drugs and feed additives).

The SFDA’s organisational structure is divided into three primary sectors—food, drugs, and medical devices. Each sector encompasses multiple procedures and registration pathways, depending on the product’s risk level, classification, and intended use.

For instance, food may be categorised as either regular food or food supplements. Medical products might range from high-risk medical devices to low-risk medical supplies. Meanwhile, pharmaceuticals include innovative drugs, generic drugs, health supplements, herbal products, and cosmetics. Each product category has its specific requirements.

Beyond product approvals, the SFDA inspects and licenses entities such as manufacturers, warehouses, consulting firms, and Marketing Authorization Holders (MAH). Its regulations sometimes extend to brand owners, license holders, and raw materials suppliers.

Companies eligible to apply to SFDA

Local regulations allow specific legal entities to submit applications to the Saudi FDA. The following are the available options for local and international companies.

Local Companies

Local Saudi companies can submit their applications directly to the SFDA, provided they have the appropriate license for the relevant activity and the necessary access to the related electronic systems. Examples of local companies that may qualify include:

• Distributors
• Manufacturers

International Companies

International companies can submit to SFDA through one of the following entities:

• Distributors
  While delegating product registration responsibilities to a distributor may be cost-effective, it often falls short in other critical areas. Distributors may lack the focused attention, regulatory expertise, and strategic alignment needed for streamlined approvals. Additionally, commercial conflicts of interest and longer timelines can further complicate the registration process.
• Foreign investor license
  An international company may establish a local entity as a foreign investment firm through the Ministry of Investment. Then, it can apply directly to the SFDA.
• Scientific office
  International pharmaceutical companies can hire a Saudi-licensed pharmacist to set up and oversee a scientific office, manage product life cycles, and register new products directly with the SFDA. This approach is well-suited for established businesses in Saudi Arabia that plan to build their in-country team.
• Consulting Company
  International companies can register their products through an SFDA-licensed consulting firm or an authorised representative, which can handle the registration process on their behalf. This approach offers a range of benefits, including:
  • Neutral, Non-Commercial Partnership: Work with an independent entity focused purely on your regulatory success.
  • Professional Regulatory Support: Access expert guidance to navigate complex regulations efficiently and confidently.
  • Data Privacy Protection: Maintain strict confidentiality of proprietary information throughout the registration process.
  • Enhanced SFDA Communication: Benefit from proactive, specialised engagement with the Saudi Food and Drug Authority to streamline approvals.
  • Full Control Over Licenses and Distributors: Retain complete authority over licensing and distribution arrangements.
  • Accelerated Access:
    Instead of spending months searching for and negotiating with distributors before even initiating the product registration process, a specialised consulting firm can register your products concurrently while identifying the right international distribution partners. By streamlining these efforts, you gain a faster path to market.
    Contact us for more details.

SFDA Approval

The SFDA approval process involves a comprehensive scientific and regulatory review, ensuring that products are safe and effective for public use. This stringent evaluation is reserved for highly regulated product categories and can vary depending on the type of application and submission pathway within the authority.

Once the application reaches the product manager, they distribute the relevant sections of the file to one or more assessors in the appropriate departments. Each assessor evaluates the submitted information against the applicable SFDA standards and compiles a report outlining comments and deficiencies. The product manager then consolidates this feedback and sends it to the applicant as an “SFDA Inquiry” or “Request for Information” (RFI).

Certain products, such as pharmaceuticals, undergo additional layers of scrutiny. These can include departmental meetings, laboratory testing, Good Manufacturing Practice (GMP) inspections, pricing committee evaluations, and final approval by the main drug committee.

Ultimately, the SFDA grants approval once the assessors have verified that all standards and requirements have been met, confirming the product’s eligibility for the Saudi Arabian market.

The timelines for the approval process vary according to the procedure type, the number of deficiencies identified, the frequency and complexity of RFIs (Requests for Information), and the applicant’s responsiveness.

It’s important to note that certain products—like basic food items and cosmetics—are handled differently, using a procedure known as “Notification” or “Listing.” Under this approach, the authority does not conduct a full review, and the applicant is responsible for ensuring product compliance.

The following section provides a more detailed overview of the approval process for all product registration applications.

SFDA Registration

SFDA registration is the process of compiling and submitting a product file to the Saudi Food and Drug Authority (SFDA) for evaluation. Upon approval, the product is added to the SFDA database, and a registration certificate is issued, confirming its eligibility for marketing in Saudi Arabia.

The internal registration process begins when an applicant submits the required documentation to the SFDA, which evaluates and verifies the submission against applicable standards. Certain products—such as basic food items and cosmetics—require only a listing in the SFDA database, with no extensive review or approval needed. In contrast, other product categories must undergo thorough scientific and technical assessments before being granted marketing authorisation. Additionally, registering entities and facilities may involve a detailed file evaluation and, in some cases, an on-site inspection.

It’s important to note that the term “SFDA Registration” applies broadly, encompassing even basic listings of products and facilities in the SFDA database. In contrast, “SFDA Approval” or “Authorisation” typically refers to more stringent regulatory reviews required for highly regulated products, such as pharmaceuticals and medical devices.

The following section will detail all types of SFDA registrations, including products, manufacturers, MAHs, warehouses, and distributors.

Product Registration

Pharmaceuticals

The Saudi FDA’s drug sector publishes related guidelines, assesses drug registration applications, and issues marketing approvals and licenses.

It publishes the drug registration requirements for chemical entities, biologicals, biosimilars, radiopharmaceuticals, health products, herbal products, generics, and veterinary drugs.

The SFDA links the drug marketing authorisation (MA) to three entities:

1. The Marketing Authorisation Holder (MAH)
   – MAH is the owner of the MA in Saudi Arabia.
   – MAH must be a manufacturing company (With a few exceptions).
   – MAH can change or add distributors and manufacturers at any time.
   – MAH is always an international or local manufacturer, never a distributor or a consulting company.
   – MAHs should keep MAs under their SFDA account, not with distributors.
2. The Manufacturer
   One or more manufacturers are allowed.
3. The Distributor
   One or more distributors are allowed.

The SFDA registration applications come in several types, as follows:

Human Drug Products

This application type comprises different medicinal drug products, such as new chemical entities (NCE), known active substances, biologicals (vaccines), biosimilars, radiopharmaceuticals, and generics. The application can go through one or more of the following procedures and designations:

• Drug Registration (Regular pathway)
• Priority Review Procedure
• Abridged and Verification Procedures
• Conditional Approval Procedure
• Breakthrough Medicine Procedure
• Orphan Drug Designation

Read more about labelling requirements, Pharmacovigilance (QPPV), and Clinical Trials in Saudi Arabia.

Herbal and Health Products

Companies must register herbal and health products under the drug sector, which requires a CTD or eCTD file for registration.

Veterinary Drug Products

This application includes new veterinary drugs, biologicals, generics, herbal, and health animal products. The application can go through one or more of the following procedures:

• Drug Registration (Regular pathway)
• Abridged and Verification and Procedures

Medical Devices

Medical device regulations in Saudi Arabia are evolving each year, keeping pace with global advancements in the field.

Below are two recent, noteworthy regulatory updates in the Kingdom:

• January 2022
  Since then, companies can no longer use the Global Harmonisation Task Force (GHTF) registration pathway. Instead, they must submit a comprehensive Technical File Application (TFA) for medical device registration to obtain Medical Device Marketing Authorization (MDMA). The TFA requirements in Saudi Arabia closely resemble the standards set forth by the EU Medical Device Regulations (MDR).
• September 2022
  The SFDA has cancelled the Medical Device National Registry (MDNR) application process for low-risk devices and now requires Medical Device Marketing Authorization (MDMA) for all risk categories. Additionally, this change makes appointing an authorised representative mandatory for low-risk devices.

Cosmetics

Companies must register their cosmetic products before offering them in the Saudi Arabian market. Unlike other product categories, the cosmetics registration process follows a “Notification Procedure.” This means that the SFDA will not necessarily review the submitted data, and its system will list the product in its database even if it does not fully meet the applicable cosmetic standards at the time of listing.

Consequently, the applicant must ensure the product complies with all relevant standards before submitting the application.

Once the cosmetic product is listed, SFDA’s compliance checks occur both in the marketplace and, most notably, at the port of entry. During this inspection, SFDA officers verify product labels on every incoming shipment and request a Certificate of Conformity (CoC) for each batch. If a product fails these checks, shipments may be rejected at the border, or items already in the market could be withdrawn.

To avoid such complications, it is crucial that all submitted documentation and product attributes strictly adhere to the Saudi and GSO standards throughout the entire submission and importing process.

Food

Compared to other product categories, food registration requirements are generally simpler. Nonetheless, the SFDA still requires that the ingredients, labels, manufacturers, and raw material sources meet all relevant regulations and GSO (GCC) standards. While the SFDA does not conduct a comprehensive label review at the time of registration, it relies on the applicant to ensure compliance. The SFDA’s primary evaluation occurs at the port of entry, where labels and documentation are inspected to verify adherence to the prescribed requirements.

Food Supplements

Food supplements can be classified as food, health, or herbal products according to their ingredients and medical claims. A product classified under the food sector must be registered using the distributor’s account. In contrast, supplements categorised as health or herbal products can be registered directly with the SFDA, either through a consulting firm or via a distributor.

Sanitisers and Disinfectants (Biocides)

The SFDA oversees the registration of biocides, such as sanitisers and disinfectants. The classification depends on their intended use:

• Biocides for Human Use: Classified as health products and require SFDA registration.
• Biocides for Medical Instrument Use: Considered medical devices and must follow the relevant SFDA procedures.

Determining the correct pathway often requires input from a subject matter expert who can advise on potential adjustments to the applicable process.

Biocides not intended for human use are regulated by the Saudi Standards, Metrology, and Quality Organization (SASO) or the Ministry of Agriculture. These products may require a certificate of conformity issued through the Saber platform.

Feed Additives

Registering animal feed additives (also referred to as fodder or forage) can vary in complexity based on ingredient composition and product claims. While standard approvals typically take two to four weeks, more complex products may require several months due to the need for scientific committee evaluations.

Tobacco and Nicotine Products

In May 2015, a royal decree made the SFDA the official regulatory body for tobacco. It became responsible for tobacco standardisation, registration, clearance approval, and entity licensing. It also monitors the components and emissions of tobacco & nicotine products. The current Tobacco Regulations are:

In May 2015, a royal decree designated the SFDA as the official regulatory authority for tobacco products in Saudi Arabia. Since then, the SFDA has managed all aspects of tobacco oversight, including standardisation, clearance approvals, and licensing entities involved in the tobacco supply chain. Additionally, it monitors the components and emissions of tobacco and nicotine-containing products.

Current Tobacco Regulations Include:

• Standards
  SFDA applies the Gulf (GCC/GSO) standards concerning specifications and components.
• Packaging
  Plain packaging for cigarettes is enforced.
• Electronic Cigarettes
  The authority issued specific requirements and standards for e-cigarettes, heated cigarettes, and other related devices.
• Licensing
  Local distributors must obtain a special license to import and commercialise tobacco in Saudi Arabia.

Manufacturer Registration

Pharmaceutical Manufacturer

Pharmaceutical manufacturer registration is required for sites producing drugs, health products, and herbal products. These sites are subject to mandatory inspection and fee payment. For more, read GMP inspection.

Food Manufacturer

Only poultry, dairy, and fish product manufacturers are subject to registration and inspection. This also includes their related slaughterhouses and suppliers. Inspection might be waived for some cases.

Medical devices Manufacturer

The need for inspection and registration applies to local medical device manufacturers and selectively to international ones.

Other Manufacturers

Other types of product manufacturers are not required to be inspected. They must submit a manufacturer license (ML) and other qualifications, such as ISO certifications and related audit reports.

Warehouse Registration

Local Saudi warehouses must receive an SFDA license before they start their activities. This includes all commercial activities involving any of the authority’s regulated products. The permit requires applying good distribution practice (GDP), quality system, ISO, and other requirements.

Distributor Registration

The distribution license is almost the same as the warehouse license. Adding importation activity is a must in addition to opening the required distributor accounts.

Timelines

The registration timelines depend on the application type detailed in our post: SFDA Timelines.

Fees

Government fees range from free for cosmetics to as little as $267 for a product classification to as high as $49,066.6 for a drug manufacturer registration. For more details about all types of governmental charges, read SFDA Fees.

SFDA Certificate

Regulatory Consulting and Services

At PharmaKnowl Consulting, we provide life science companies with the following services:

SFDA Registration Services

Securing SFDA approval for your products is at the heart of what we do. Our dedicated team of Riyadh-based pharmacists and biotechnologists can seamlessly integrate with your organisation, providing expert support and guidance throughout the registration process.

Local Agent and Representation

International companies can consider PharmaKnowl as a non-commercial local agent (for pharmaceutical products) or an authorised representative (for medical devices), allowing them to access professional regulatory support, streamlined meetings with the SFDA, and expert guidance. This approach lets you maintain distributor relationships while benefiting from dedicated regulatory expertise.

Clinical Research

Our clinical team provides comprehensive clinical trials and research support, including patient recruitment, site management, data collection, and regulatory submissions.

Regulatory Project Management

Our regulatory project management services ensure seamless compliance with Saudi regulations. We have successfully managed projects such as MA transfer (MAT), Technology Transfers, licensing, mergers and acquisitions, local manufacturing, and more.

Our clinical team offers end-to-end support for clinical trials and research initiatives. This includes protocol development, site management, patient recruitment, data collection, regulatory approvals, and general trial operations.

Life cycle management

Our life cycle management services ensure compliance for marketed products to maintain continuous supply. We file variations and renewals on time and submit stock and drug labelling information as per SFDA requirements.

Regulatory intelligence

Our regulatory intelligence service provides comprehensive insights into the latest SFDA regulatory requirements and updates in Saudi Arabia. We help you stay ahead of compliance changes, streamline your product approvals, and quickly navigate complex regulatory landscapes.

Pharmacovigilance

Our pharmacovigilance services in Saudi Arabia ensure compliance with SFDA regulations, providing comprehensive support from adverse drug reaction reporting to risk management plans. Our Saudi QPPV and safety expert team handles individual case safety reports, signal detection, and regulatory submissions, ensuring patient safety and regulatory adherence.

For more information, Contact Us.