SFDA Drug Registration Requirements & Approval Process

The Saudi Food and Drug Authority is the agency responsible for drug regulation in the kingdom of Saudi Arabia. The pharmaceutical industry seeks its approvals for marketing, manufacturing, and clinical studies before commencing in any of these activities. Therefore, SFDA registration is important to secure in the shortest timelines. The SFDA drug registration requirements had evolved significantly during the past decade, especially in the submission particulars. It gradually transitioned from the paper format, through CTD, NEES, reaching the current eCTD file.

In this blog post, we will outline the SFDA drug registration requirements with a background on the application approval process. It should only cover the high-level points to help in drawing the big picture of the drug submission requirements for those who are new to the Saudi market.

Planning for Drug Registration

The best practice toward an SFDA drug approval is to start the registration project by developing a regulatory strategy. Especially for companies that are new to the Saudi market. From experience, a good regulatory strategy is necessary to support an accurate business decision and a troubleless drug registration process. This is because it provides the needed visibility on the forthcoming regulatory impact on all aspects.

Since compliance and registration requirements are the foundation of the regulatory strategy, having it developed prior to the registration process will eventually contribute to the progress of your submission project. It even makes your project execution more effective and reliable.

Read More: Development of a Regulatory Strategy for the Saudi Market.

SFDA Drug Registration Requirements

As regulatory professionals, the most common question we receive is (what are the registration requirements?) which cannot be responded to by a confined checklist. Every required document has its compliance measures. Let alone the needed comprehensive due diligence which goes further off the drug file.

Therefore, what we provide here is just to enable the primary market researchers to measure the depth and length of the process. In this direction, we segmented the requirements in an effort to simplify such interconnected processes. They are the following four requirements sections that we will explain in detail.:

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

Drug Registration Guidelines

According to the drug type, we included below the related SFDA drug registration guidelines. Note that it is recommended to submit an SFDA classification request to determine the applicable submission type for your borderline products.

Human drug registration guidelines

  • Data Requirements for Human Drugs Submission
  • SFDA Stability Guidelines
  • SFDA Drug Master File (DMF) guidelines
  • SFDA SPC, PIL, and Labeling requirements
  • 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
  • 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

SFDA Drug Dossier Requirements

Dossier Files

  • New drug
    New molecules introduced to the Saudi market including biologics, biosimilars, and radiopharmaceutical.
    • 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, 5.3.1.2, 5.3.1.3, 5.3.1.4, 5.3.7, and 5.4
  • Herbal & Veterinary:
    There are too many variables for Herbal, health, and vet dossiers. This is according to the product attributes and ingredients which can not be summarized in a few points here.

Dossier Format

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

Drug Application

The drug registration application is to be filled and submitted through the Saudi Drug Registration (eSDR) system which enables the applicant 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 applications in eSDR comes in three major types with more sub-types, as follows:

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

Application Fees

The below are the SFDA drug registration fees for the main application forms. The cost of registration of additional strengths or pack sizes are much less:

  • New human drug: SAR 95,000 ($25,333.33)
  • Generic human drug: SAR 40,000 ($10,666.66)
  • Health & herbal product: SAR 20,000 ($5,333.33)
  • Veterinary drug: SAR 5,000 ($1,333.33)

In addition to that, companies have to pay eSDR portal fees, which are ranging from SAR 20,000 ($5,333.33) for a new drug to SAR 1000 ($266.66) for a veterinary drug.

Application Submission

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

SFDA drug registration process
SFDA Sourced

Validation

Technical Validation

Upon reception of the dossier, SFDA performs an electronic validation on the compiled eCTD according to the SFDA eCTD Validation Criteria. Worth mentioning that even valid eCTD dossiers could be rejected due to other types of technical errors.

Business Validation

This is a manual primary business validation process 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 discovered during the evaluation process.

In this 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 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.

Approval Process

Understanding the approval process and its journey through the SFDA evaluation departments is essential for the regulatory professionals since it puts the registration requirements into context and helps in determining the application progress.

The approval process is basically the evaluation stages the application will go through until it gets approved. In the drug sector, the drug file evaluation takes place in a parallel module allowing multiple departments to assess the application at the same time.

The SFDA evaluation departments are as follows:

Evaluation

Quality

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

Benefit & Risk Evaluation

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

Inspection

This department is responsible for the evaluation and SFDA GMP certification of drug manufacturers.

Testing

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

Pricing

The pricing evaluation is the last SFDA evaluation stage. This department performs a pharmacoeconomic study on the drug and generates a report for the SFDA pricing committee. The recommended price by the pricing committee requires final approval from the registration committee.

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 expiry date of this document is 5 years.

Priority Review

There two accelerated registration routes in the SFDA. One is based on the added value of the drug which is SFDA priority registration. While the other route is for those which are already FDA or EMA approved, it is named SFDA verification and abridged registration.

Drug Variations

Changes in any administrative or technical information within the approved drug file requires submission of a variation application. This has to be approved prior to importing the updated drug with the new specification.

Drug Renewals

Companies must maintain a valid registration certificate by submitting a renewal application before the expiration of the license. This is applicable for marketed and non-marketed products.

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