Registering a product with the Food and Drug Authority

About the SFDA

The Saudi Food and Drug Authority (SFDA) regulates human and animal-consumed products to protect the public from harmful, low-quality, falsely claimed, counterfeit, and useless products. Their ultimate responsibility is to ensure the product’s safety, efficacy, and quality.

The SFDA is the most stringent authority in the MENA region due to their continuous development of Saudi pharmaceutical laws and investment in the growth of local scientists since 2004. Their progress culminated 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). Hence, the GCC and MENA countries regard Saudi Arabia as a reference country.

SFDA Regulations

The Saudi FDA regulations cover three primary industries: food, pharmaceuticals (drugs), and medical devices. It also regulates other healthcare products such as herbals, food supplements, cosmetics, biocides, medical supplies, pesticides, and animal health products such as veterinary drugs and feed additives.

The authority comprises three main sectors: food, drug, and medical devices. Each has many procedures and routes of registration that depend on the product type and nature. The food comes into two types: regular food and food supplement registration. Medical products are high-risk medical devices or low-risk medical supplies. Then, we have pharmaceutical products, including new innovative drugs, generic drugs, health (supplements), herbals, and cosmetics. According to the Saudi FDA regulations, every type has different requirements.

In addition to products, the authority inspects and licenses related entities, such as manufacturers, warehouses, consulting firms, and marketing authorisation holders (MAH). In some cases, the SFDA regulations might also apply to brand owners, license holders, and raw materials suppliers.

Types of Applicants

We will start with who can submit before what to submit. The regulations allow specific legal entities to approach the Saudi FDA for application submission.

The following sections will discuss the available options for local and international companies.

Local Companies

Local Saudi companies can directly submit their applications to the SFDA. However, they must be licensed for the related activity and have proper access to related electronic systems. Commercial activities include food, drugs, herbals, medical devices, cosmetics, veterinary drugs, animal feeds, and pesticides.

International Companies

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

• Distributors
  Delegating product registration to the distributor is a common option because of the cost advantage, but it is usually weak and in a prolonged timeline.

• Foreign investor license
  International companies can establish their official presence in Saudi Arabia as foreign investment companies through the Ministry of Investment. Then, they can apply directly to the SFDA.

• Scientific office
  International pharmaceutical companies can hire a Saudi-licensed pharmacist to establish and manage a scientific office and be able to register products at the SFDA directly.

• Consulting Company
  International companies can register their products through an SFDA-licensed consulting company such as PharmaKnowl. The consulting company can submit the registration application on their behalf. This option comes with many advantages, such as:

  • Neutral / Non-commercial partner

  • Professional regulatory support

  • Data Privacy

  • Advanced SFDA communication

  • More control over licenses and distributors

  • Faster access:
    For example, rather than starting the registration project by spending months on distributor search and negotiations, a consulting company can submit the products for registration during the international company search for a distributor. Contact us for more details.

SFDA Approval

The SFDA approval is a rigorous scientific and regulatory review process to ensure that products are safe and effective for public use. It applies only to highly regulated products and differs according to the application type and route inside the authority.

The approval process starts when the submitted application reaches the product manager, who distributes the file content between one or more assessors in the related departments.

Then, the assessor evaluates the submitted information and creates a report of comments and deficiencies that the product manager gathers and sends to the applicant as “SFDA inquiries” or “Request for Information” (RFI).

Some products, such as pharmaceuticals, go through additional steps, such as department meetings, lab tests, GMP inspection, pricing committees, and voting of the main drug committee.

Eventually, the authority approves the product when the assessors find the file compliant with all applicable SFDA requirements.

The timelines for the above process depend on the procedure type, the number of deficiencies, RFI waves, and the time the applicant takes to respond to the RFIs.

Note that the authority does not entirely assess simple products such as food and cosmetics since their procedure is “Notification” or what is also called “Listing”, which makes the applicant responsible for compliance before submission.

The sections below describe the approval process for all types of product registration applications in more detail.

SFDA Registration

SFDA registration is the process of preparing and submitting a product file to the authority to assess its eligibility for marketing in Saudi Arabia. The approved products appear in the SFDA database and receive a registration certificate. It is worth noting that the technical term “SFDA Registration” can generally be used for products and facilities (warehouses, manufacturers), unlike “SFDA Approval or Authorisation“, which are more for highly regulated products such as pharmaceuticals and medical devices.

The internal registration process starts when the applicant submits the SFDA requirements for assessment and verification against the applicable standards. Some products, such as simple food and cosmetics, might not need review and approval; they only require listing in the authority’s database. In contrast, other products must undergo scientific and technical scrutiny before receiving marketing approval. On the other hand, registration of entities and facilities requires file assessment and inspection in some cases.

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 and updates 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, but a few exceptions exist.
   – MAH can change or add distributors and manufacturers at any time.
   – MAH is always the international or local manufacturer, never the distributor or consulting company.
   – MAHs should keep MAs under their SFDA electronic account and maintain them by their staff or consulting partner; some choose to leave them under the distributor account.

2. The Manufacturer
   One or two.

3. The Distributor
   One or more.

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 and 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 Products

This application includes new drugs, biologicals, generics, herbal products, 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 becoming more developed yearly, aligning with the global improvement in medical device regulations. Here are two examples of the latest significant updates in Saudi Arabia:

• January 2022
  On this date, companies can no longer use the Global Harmonisation Task Force (GHTF) registration route; instead, they must submit a complete Technical File Application (TFA) for medical device registration to receive Medical Device Marketing Authorisation (MDMA). The specification of the TFA in Saudi Arabia is similar to that of EU medical device regulations (MDR).

• September 2022
  The SFDA cancelled the Medical Device National Registry (MDNR) application for low-risk medical devices and enforces (MDMA) for all risk types. This also made the appointment of an authorised representative for low-risk devices a must.

Cosmetics

Companies must register their cosmetics before marketing them in Saudi Arabia. The cosmetics registration process is different because it is a “Notification Procedure,” meaning the SFDA will list the product in its database even if it does not comply with the cosmetics standards. Therefore, the applicant must ensure compliance with all standards before submitting their application to the authority.

After listing the cosmetic product, the authority’s compliance review takes place in two locations: in the market and, most commonly, at the port of entry, where SFDA inspectors check the compliance of product labels in every shipment and request a certificate of conformity (CoC) for every batch.

Therefore, submitted files in the cosmetic application must comply with all applicable Saudi and GSO standards to avoid rejection of shipments at the port or withdrawals from the market.

Food

Generally, food registration requirements are less complicated than those for other types of products. However, their ingredients, labels, manufacturers, and raw material sources must all comply with the SFDA regulations and GSO (GCC) standards. The authority does not thoroughly review their labels; they leave the compliance review to the applicant and only check compliance at the port of entry.

Food Supplements

Food supplements can be classified as food products, health products, or herbal products according to their ingredients and medical claims.

Sanitisers and Disinfectants (Biocides)

The SFDA regulates biocides such as sanitisers and disinfectants and requires their registration. If used on humans, they are classified as health products; if used to sanitise medical instruments, they are considered medical devices. In most cases, an expert must review such products to determine their pathway and provide advice on how to alter the applicable procedure if possible.

Biocides not for human use are regulated by the Saudi Standards, Metrology, and Quality Organization (SASO) or the Ministry of Agriculture. They require a certificate of conformity from the Saber platform.

Feed Additives

Animal feed additives (also called fodder or forage) registration could get complicated depending on the complexity of the ingredients and the label claims. The approval process should take 2-4 weeks, but it might take months for advanced products that require the involvement of the scientific committees.

Tobacco

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:

• Standards
  SFDA applies the Gulf (GCC/GSO) standards concerning specifications and components.

• Packaging
  SFDA is enforcing plain packaging for cigarettes.

• 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. Currently, global manufacturers are required to appoint an authorised representative in Saudi Arabia.

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

What is an SFDA Certificate

A governmental document issued by the SFDA indicates that a company or product is registered or granted approval or authorisation for marketing in Saudi Arabia. This certificate is issued after completing the registration process. It gives the green light to manufacture and market. It also allows clearance of imported product shipments at the Saudi ports.

The image below is the header of an SFDA certificate.

How do I get SFDA approval?

It is by applying the required standards and complying with the SFDA requirements. To learn more about the process, refer to the related product type in this article.

Regulatory Consulting and Services

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

SFDA Registration Services

Product registration to receive SFDA approval is our core service. Our dedicated team of pharmacists and biotechnologists, who are physically based in our Riyadh office, is ready to join your team and support your projects.

Local Agent and Representation

International companies may choose Pharmaknowl as a non-commercial local agent (for Pharma products) or an authorised representative (for MedTech) to benefit from our professional regulatory support, efficient authority meetings, and expert advice. Explore this option while maintaining your distributors.

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.

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.