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SFDA Registration and Approval Process

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The Author

Mohammed Jobran

Regulatory Consultant, 18 years of experience. Worked for SFDA and the industry. Pharmacist, BSc, MSc.

Before marketing drugs, food, and medical devices in Saudi Arabia, companies must register their products with the Saudi Food and Drug Authority (SFDA) to receive the marketing approval. This SFDA approval is also known as SFDA registration. It is a review process to ensure the safety, efficacy, and good quality of the drugs and medical devices. The authority also ensures the safety of food, cosmetics, and other types of products that we will cover in this post.

The approval process starts when the company submits the SFDA product registration requirements in the application. The authority then performs a scientific assessment to verify compliance and the product that proves adherence to the regulations and applicable standards will be granted marketing approval.

This approval is provided in an “SFDA certificate” document, which allows companies to start their marketing activities and clear their shipments into the Saudi market. In this article, we will detail the registration and approval process for different types of products subject to Saudi regulation.

Background

Regulatory authorities control product placement in the markets to protect the public from harmful (unsafe), low-quality, falsely claimed, counterfeit, and useless products. Their ultimate responsibility is to ensure the product’s safety, efficacy, and quality.

The SFDA is considered the most stringent authority in the MENA region. It is the first adopter of international standards with additional laws. Hence, Saudi Arabia is regarded as a reference country for the GCC and MENA regions. Their continuous development of regulations culminated in 2021 when SFDA became a full regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Therefore, marketing in Saudi Arabia requires companies to obtain an SFDA registration to be legally permitted to market and use the approval to facilitate the importation and clearance process at the Saudi ports. Having an SFDA Certificate for the product proves that it has achieved the SFDA approval.

Scope

The SFDA regulates 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 (fodder, forage).

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.

Saudi FDA Regulations

Regarding the application submission, the regulations allow specific legal entities to approach the Saudi FDA. The following sections will discuss the available options for local and international companies, it answer the usual question; who can directly submit to SFDA?:

Local Saudi Companies

Local Saudi companies can submit their applications to the SFDA directly. However, they must be licensed for the related activity and have proper access to related authority electronic systems. The scope of activities includes 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
    This is the well-known option where international companies can delegate their local distributors to register on their behalf.
  • Foreign investor license
    International companies can establish their official presence in Saudi Arabia as foreign investment companies and apply directly to the SFDA. Note that there will be a commitment to the minimum invested capital required by the Ministry of Investment, annual government fees, profit tax, and other usual operational expenses.
  • Scientific office
    Pharma international companies can establish a scientific office, hire pharmacists, license the office by SFDA, and then make direct submissions to the authority.
  • Consulting Company
    International companies can register their products through an SFDA-licensed consulting company such as PharmaKnowl Consulting, which can represent the foreign company in Saudi Arabia and submit the registration application on their behalf. This is a great option with many advantages, such as:
    • Non-commercial and independent partner.
    • Professional regulatory support.
    • Privacy of data
    • Advanced SFDA communication
    • International company is still the product license holder (MAH).
    • More control over commercial partners.
    • Faster access:
      It is a significant time-saving option that provides accelerated market access. E.g. rather than waiting several months to appoint a distributor, PharmaKnowl will submit the products for registration while the international company evaluates, negotiates, and signs with one or more distributors. Contact us for more details.

SFDA Approval Process

The SFDA approval process is assessing the submitted product file for registration by different departments inside the related SFDA sector. The final SFDA approval is associated with the product’s full compliance with applicable laws, standards, and guidelines requirements. The approval timelines depend on the procedure type, the number of deficiencies, and the time needed to respond to inquiries.

In the sections below, we describe in detail the different types of product registration applications.

SFDA Product Registration

The authority is structured into three main sectors. Food, Drugs, 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 classified as high-risk medical devices or low-risk medical products or 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 a different set of requirements. We will discuss every product type in more detail in the below sections.

Drug

Pharmaceutical regulation is the responsibility of the drug sector in the Saudi FDA including chemical entities, biologicals, biosimilars, radiopharmaceuticals, health products, herbal products, generics, veterinary drugs, and others.

The authority publishes and updates the related guidelines, assesses drug registration applications, and issues marketing approvals and licenses. The granted drug marketing authorisation MA is linked to three entities:

  1. The Marketing Authorisation Holder (MAH): This entity owns the marketing authorisation; it is the same MAH reflected in the CPP for international companies. Therefore, the local Saudi company (e.g., consulting, warehouse, distributor) has no control over the license even if the MAH has no presence in the country. Note that a non-manufacturing company cannot legally be an MAH in Saudi Arabia except in some cases; contact us for support on this point.
  2. The Manufacturer: Local or international finished product manufacturing site. A drug can be registered with one or more manufacturers.
  3. The agent: A local Saudi company licensed for drug activity.

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

Human Medicinal Product

This application includes new chemical entities, known active substances, biologicals (vaccines), biosimilars, radiopharmaceuticals, generics, and health products. The application can go through one or more of the following procedures and designations:

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

Herbal Product

Herbal products for human medical use need to be registered under the drug sector. SFDA requires a complete CTD or eCTD file for registration.

Veterinary Product

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

Medical Devices

Medical device regulations in Saudi Arabia are becoming more advanced every year. This is to cope with the global advancement toward more stringent medical device regulations. Here are two examples of the latest major updates:

  • From 1 Jan 2022, the authority required companies to submit the full product Technical File (TFA), similar to the EU MDR. SFDA no longer accepts medical device files through the Global Harmonisation Task Force GHTF route (e.g. US FDA, EU CE, Japan).
  • Starting in September 2022, the SFDA stopped the simple registration route for low-risk medical devices. Instead, they all have to secure medical device marketing approval MDMA just as any high-risk device by providing the necessary technical file.

Read more in Medical Device Registration | Authorised Representative.

Cosmetics

Cosmetics regulation is also under SFDA jurisdiction. Their registration is in the form of a notification procedure, which means that SFDA doesn’t necessarily review the content of the submitted files when a company is listing a cosmetic product. Therefore, the compliance responsibility falls ultimately on the applicant since SFDA will list it in their database whether it is fully complied with or not.

For example, a product with a prohibited substance or claim might pass and be listed in the SFDA if the applicant submitted it without an expert review.

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

Read more about cosmetics registration.

Food

Generally, food registration requirements are less complicated than other types of products. However, food product ingredients, labels, manufacturers, and raw material sources must all comply with the SFDA regulations and GSO (GCC) standards. The food sector receives different types of food applications, such as:

  • Simple Food
  • Advanced Food
  • Animal feed
  • Pesticides

Food Supplements

The registration of Food Supplements might fall under the food sector in the advanced food application or the drug sector in the health and herbal application if it contains high levels of vitamins and minerals or medical claims.

Biocides Registration

Such as sanitisers and disinfectants are to be registered in SFDA as health products in the drug sector if they are used on humans or as medical devices if they are used on medical instruments. In most cases, an expert has to review such products to determine their pathway and provide advice on how to alter the applicable procedure if possible.

Other types of biocides which are not for human use can be registered under the Saudi Standards, Metrology and Quality Organization (SASO) through their SABER portal by the importer. Note that such products although not for human use might fall under SFDA in certain cases, contact us for support. In addition, such products for animal use are to be registered with the Ministry of Agriculture for import permission.

Tobacco

In May 2015, Saudi’s tobacco law was updated by a royal decree to include a significant change to make 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) standards known as (GSO) 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

Drug

Manufacturer registration is required for sites producing drug, health, and herbal products. they are subject to a mandatory inspection and payment of fees. For more about read SFDA GMP Manufacturer Registration.

Food

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 according to risk evaluation.

Medical devices

Registration with inspection is mandated however it is gradually implemented as of 2024. Currently, every legal manufacturer must appoint an authorized representative in Saudi Arabia.

Others

Other types of products are mostly not required to be inspected or to pay fees. They must only submit a manufacturer license (ML) and other qualifications such as ISO certifications and related audit reports.

Timelines

The product registration timelines depend on the product application type. For more details, read SFDA Timelines.

Fees

The government fees range from free of charge for cosmetics to as little as $267 for a product classification, reaching as high as $49,066.6 for a drug manufacturer registration that has different levels of fees. For more details about all types of governmental charges, read SFDA Fees.

SFDA Certificate

What is an SFDA Certificate?

It is a governmental certificate issued by the SFDA that indicates the product is allowed to be marketed in Saudi Arabia. This certificate is issued after completing the registration process of a product or a manufacturer.

To receive this certificate, the authority reviews the application content for compliance with safety, quality, and efficacy standards and then approves (certifies) it. The certification is a document called an SFDA certificate that reflects SFDA approval for the company to market the product in Saudi Arabia.

The images below are examples of a license for an entity and a registration certificate for a drug product:

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 support companies in all of the above SFDA services and more, such as:

  • Distributor Search
  • Local manufacturing and technical transfers
  • Marketing authorisation transfer projects (MAT)
  • Authorised Representative in Saudi Arabia
  • Legal Entity Establishment
  • Provision of insights and regulatory intelligence information
  • Pharmacovigilance and LQPPV services
  • Product Registration
  • Life cycle management

For more information: Contact Us.

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Need Support?

We support global Pharma and Medical Devices companies in the Saudi market with professional regulatory services. Send us your request to kick off your SFDA project.

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The Author

Mohammed Jobran

Regulatory Consultant, 18 years of experience. Worked for SFDA and the industry. Pharmacist, BSc, MSc.

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