SFDA Drug Registration Requirements

In this post, we aim to outline the SFDA drug registration requirements and the drug approval process. It will be a high-level coverage to help you draw the big picture of the main drug registration procedures in SFDA and their related application requirements. This should be useful for those who are new to the Saudi pharmaceutical regulations.

For other types of products:
SFDA Medical Devices Registration
Cosmetics Registration
SFDA product registration


The Saudi Food and Drug Authority (SFDA) regulates pharmaceutical (drug) products in Saudi Arabia hence determines the drug registration requirements. These requirements have evolved significantly since 2009 with the adoption of the ICH guidelines. The submission particulars had greatly transitioned from the paper format, to CTD, then NEES, to the current eCTD file. Therefore, to help you prepare for the Saudi regulatory requirements, it is essential to know what you are going to encounter during the registration process.

Planning For Drug Registration

When preparing for an SFDA registration project, the best practice is to s tart by developing a regulatory strategy. Especially for companies new to the Saudi market. A good regulatory strategy is necessary to devise an accurate business decision and a smooth registration process. It provides the needed visibility on the forthcoming regulatory impact on all functions.

Since compliance and registration requirements are the foundation of the regulatory strategy, having it developed before starting the registration process will eventually contribute to your project’s positive progress and makes its execution more effective and reliable. For more about that, you may read our article Development of a Regulatory Strategy for the Saudi Market.

SFDA Drug Registration Requirements

As a regulatory professional, the most common question I receive is “what are the SFDA registration requirements?” which is hard to respond to by providing a confined checklist. This is since every required document has its own compliance measures. Let alone the needed comprehensive due diligence that goes further off the drug file.

Therefore, the information provided here is just to enable the researchers to discover the depth and length of the requirements. In this direction, I segmented such interconnected processes into four sections and will explain them in detail:

  • SFDA Guidelines
  • Drug dossier
  • Drug application & fees
  • eCTD Submission


According to the drug type, you will find below the related SFDA drug registration guidelines:

Note: Submitting an SFDA classification is recommended for borderline products i.e. those which can be a drug in a market and a cosmetic in another.

Human Drug Registration Guidelines

  • Data Requirements for Human Drugs Submission
  • Guidance for Submission
  • Conditional approval for medicinal products for human use
  • Guidance for priority review
  • SFDA Stability Guidelines
  • SFDA Drug Master File (DMF) guidelines
  • SFDA SPC, PIL, and Labeling requirements
  • The naming of Medicinal Products
  • SFDA Tamper- Evident Packaging guidelines
  • Graphic Design of Medication Packaging
  • Registration According to Verification and Abridged
  • Module 1 Specifications Guidelines for Bioequivalence
  • SFDA Biosimilars Guidelines
  • Investigational New Drugs (IND) Requirements
  • Pharmaceutical Reference Standard
  • SFDA Biowaiver Guidelines
  • Production and Quality Control of Vaccines

Herbal Drug Registration Guidelines

  • Data Requirements for Herbal & Health Products Submission (Food Supplements)
  • Guidance for Presenting PIL and Labeling Information of Herbal and Health Products
  • General Rules For Products Containing Vitamins And Minerals

Veterinary Drug Registration Guidelines

  • SFDA VNeeS specifications for the veterinary medicinal product
  • Data Requirements for Veterinary Medicinal Products
  • SFDA SPC, Leaflet, and Labeling for Veterinary Products

Drug Dossier Requirements

Dossier Files

  • New drug
    These are the innovative drugs equivalent to NDAs including biosimilars.
    • All 5 modules are required.
  • Generic drug
    • M1: All sections.
    • M2: 2.1, 2.2, 2.3, 2.5.2
    • M3: All sections.
    • M4: NA
    • M5: Only 5.1, 5.2,,,, 5.3.7, and 5.4
  • Health and Herbal Products
    • M1: All sections.
    • M3: All sections.
  • Veterinary Drug:
    • Part 1
    • Part 2
    • Part 3
    • Part 4

Note: There are many variables for Herbal, health, and veterinary dossiers based on the product attributes and ingredients.

Dossier Format

  • Human drug: eCTD.
  • Herbal and health products: CTD or eCTD
  • Veterinary drug: vNEES or CTD.

Drug Application

The SFDA drug registration application is to be filled out and submitted through the Saudi Drug Registration (eSDR). This portal is available to access by local Saudi companies; it enables the applicants to do the following:

  • Fill and export the application for module 1.
  • Pay the application fee.
  • Submit the dossier.
  • Receive and respond to assessment inquiries RFI.
  • Receive the application review decision
  • Print the registration certificate.
  • Manage the drug file life cycle (variations & renewals).

Application Types

SFDA drug registration applications in eSDR come in three major types with more sub-types, as follows:

  • Human Medicinal Product
    • New Drug
    • Biological
    • Radiopharmaceutical Drug
    • Generic (Multisource) Drug
  • Health and Herbal Product (Food Supplements)
  • Veterinary Product
    • New Drug
    • Biological Drug
    • Generic (Multisource) Drug
    • Herbal Product
    • Health product

Application Fees

Since the fee structure is complex, you may refer to our other post SFDA Fees: Details of all fees and amounts.


In the following image, you can see the application submission process that goes into two layers of validations that we will discuss next.

Source: SFDA


Technical Validation

The SFDA receives the submitted dossier and performs an electronic validation on the compiled eCTD according to the SFDA eCTD Validation Criteria.

Business Validation

This is a manual primary business validation performed on the file after passing the electronic validation. It is a step before the initiation of the actual evaluation. It aims to reduce the number of obvious file deficiencies that are usually discovered during the evaluation process.

The SFDA will validate (not evaluate) the presentation and main compliance issues such as:

  • Application type & fees
  • MAH and Manufacturer compliance and legal status.
  • Active Pharmaceutical Ingredient (API)
  • Finished Pharmaceutical Product (FPP)
  • Clinical Trials Data
  • Safety data (SPC/PIL)

Approval Timelines

  • New and Biologic human drug:
    • Registered in SRA: 280 working days.
    • Not registered in SRA: 405 working days
  • Radiopharmaceuticals: 280 working days
  • Generic human drug: 155 working days
  • New and Biologic Veterinary drug:
    • Registered in SRA: 260 working days.
    • Not registered in SRA: 385 working days
  • Generic Veterinary drug: 165 working days
  • Herbal & Health products: 155 working days.

Review and Approval Process

After knowing how to submit a sfda drug registration application, we find it essential for you to understand the internal details of the sfda approval process. Hence, the scientific assessment and the application journey through the drug sector departments. This is important so we put the registration requirements into context and to help you determine at which evaluation stage is your application.

The drug approval process consists of multiple parallel evaluation routes within the drug sector. This allows all departments to assess the application simultaneously. In below, we will go through each evaluation route in more detail.

Evaluation Department


  • Active Pharmaceutical Ingredient (API)
  • Finished Pharmaceutical Products (FPP)

Benefit & Risk Evaluation

  • Clinical evaluation
  • Bioequivalence (BE)
  • Reference Safety Information (RSI)
    • Summary of Products Characteristics (SPC)
    • Patient Information Leaflet (PIL)


This department is responsible for the evaluation and SFDA GMP certification of the drug manufacturers. Applicant should expect a mandatory GMP licensing for all drug, health, herbal, and veterinary manufacturers. This will include a site inspection by SFDA inspectors and payment of the inspection fees.

Testing (SFDA LAB)

During the SFDA drug registration, you should expect a request for samples for analysis. Sometimes, you may be able to waive this request to a later stage where the analysis is delayed so it will be performed on the first batch arriving to the Saudi market.

  • Lab analysis
  • Revision of related analysis documents
  • Request drug samples and reference standards
  • Testing commercial batches


The pricing evaluation is the last SFDA drug registration stage. This evaluation stage is not going to be in parallel with the aforementioned evaluations. This department performs a pharmacoeconomic study on the drug and generates a report for the SFDA pricing committee. The committee will set the CIF price then communicated to the applicant to accept or appeal.

Registration Committee

The SFDA main registration committee is responsible for reviewing the final comprehensive evaluation report from all departments. They make the final decision to approve or reject the application.

Registration Certificate

Approved drug applications will receive a registration certificate that entitles the company to market in Saudi Arabia. The validity of this certificate is 5 years.

Conclusion of Drug Review

After we understand that the drug application will go through an extensive assessment by SFDA experts, the applicant should expect multiple waves of inquiries (RFIs) during the process. Especially on the API, stability, clinical trials, bioequivalence, labeling (PIL/SPC), pharmacovigilance system, and QPPV.

SFDA Accelerated Drug Approval

There are two accelerated registration routes in the SFDA

  • Drug priority review procedure
    • It is based on the added value of the drug.
    • Provides 40% reduction on the standard approval timelines.
  • Orphan Drug Designation
    • Fast access for Orphan drugs with market exclusivity privileges.
    • Timelines are expected to be similar to the above priority Review procedure.
  • Verification and abridged registration
    • This is only applicable on FDA or EMA approved drugs.
    • Provides the greatest reduction in timelines.
  • Conditional Approval
    • Applicable for products that address unmet medical needs
    • Timelines are not determined by SFDA

Life Cycle Management LCM

Changes in the Registered Information

After you receive your drug approval, the maintenance process almost starts immediately. You will usually have one or more schedules updates on the registered information. They are known as variation applications that have their own procedure and requirements. Be it administrative or technical information changes, they all have to be approved by SFDA before marketing. Read more: SFDA Variation Guidelines Overview.

Drug License Renewal

Companies must maintain their products license validity by submitting a renewal application before the expiry of the SFDA certificate. This is possible 6 months ahead of the expiry date.

Read More

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