SFDA Drug Registration Requirements

In this post, we will outline the SFDA drug registration requirements with a background on the SFDA approval process. We are aiming to cover the high-level points to help draw the big picture of the drug submission requirements. We feel it is useful for those who are new to the Saudi pharmaceutical market.

For other types of products, navigate to SFDA Medical Devices Registration, Cosmetics Registration, or other SFDA products registration.

Introduction

The Saudi Food and Drug Authority (SFDA) regulates the drug products in Saudi Arabia and enforces the drug registration requirements. These requirements had evolved significantly during the past decade with the adoption of the ICH guidelines. Even the submission particulars had greatly transitioned from the paper format, through CTD, then NEES, to the current eCTD file. Therefore, to help you plan for your Saudi market entry or expansion, it is essential to know what you are going to encounter during the registration process.

Planning For Drug Registration

The best practice toward an SFDA approval is to start the registration project by developing a regulatory strategy. Especially for companies that are new to the Saudi market. A good regulatory strategy is necessary to devise an accurate business decision and a smooth drug registration process. 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 before the registration process will eventually contribute to your project progress and makes its execution more effective and reliable. Read More: 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 cannot be responded to by a confined checklist since every required document has its 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

Drug Registration Guidelines

According to the drug type, included below are the related SFDA drug registration guidelines.

Note: It is recommended to perform an SFDA classification to determine your type of product prior to initiating your compliance checks, especially if your product is known to be a borderline product.

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
  • 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
  • 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
    This is basically the innovative drugs equivilant 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, 5.3.1.2, 5.3.1.3, 5.3.1.4, 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 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 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 product
  • Health and Herbal Product
  • Veterinary Product
    • New Drug
    • Biological Drug
    • Generic (Multisource) Drug
    • Herbal Product
    • Health product

Application Fees

As a quick example, a new drug application fee is SAR151,000 + 15% VAT & its manufacturer registration, if based in North America, costs SAR161,000.

Since the fees structure is complex, you may refer to this post for more details: SFDA Fees: details of +50 types of applicable fees.

Submission

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

Validation

Technical Validation

The SFDA receives the submitted dossier and performs an electronic validation on the compiled eCTD according to the SFDA eCTD Validation Criteria. Worth mentioning that even eCTD valid 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 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 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 you can submit a drug application to the SFDA, we find it essential for you to understand the sfda internal approval process. Hence, the scientific assessment and the application journey through the departments. This is important so we put the registration requirements into context and help you later when you are determining your application progress.

The approval process consists of evaluation stages that take place in a parallel way within the drug sector. This allows multiple departments to assess the application simultaneously. Let us go through each stage in more details:

Evaluation Department

Quality

  • 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)

Inspection

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

Testing

You should expect a request for analysis samples during the file assessment, and you may be able to waive this request to a later stage, so the analysis is to be performed on the first batch arriving at the Saudi market.

  • 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 committee will recommend a price that will make the final approval from the main registration committee before communicating to the company for acceptance or appeal if applicable.

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.

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 (RFI) during the process, especially on the API sections and their related pharmacopoeias. In addition to safety inquiries (leaflets & SPC), pharmacovigilance system notes, and the presence of a Saudi QPPV.

SFDA Accelerated Drug Approval

There are two accelerated registration routes in the SFDA; the first one is the drug priority review based on the added value of the drug, which results in a 40% reduction of the normal approval timelines. While the other is the verification and abridged registration, which is only applicable on FDA or EMA approved drugs and provides the greatest reduction in timelines.

Life Cycle Management LCM

Changes on the Registered Information

After you receive your drug approval, the maintenance process usually starts immediately, where you will have in your schedule one or more changes to the registered information that you have to update at the SFDA. Those are known as variation applications, and they have their own complex procedures and requirements. Be it administrative or technical information changes, they all have to be approved by SFDA in a variation dossier. Read more here: SFDA Variation Guidelines Overview.

Drug Licesne Renewal

On the other hand, companies must maintain their registration license validity by submitting a renewal application before the SFDA certificate expires. This is possible 6 months before the certificate expiry date. Note that renewal is required even if the drug is not marketed as long as it has a registration in the SFDA.

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