SFDA Drug Registration: Requirements & Approval Process

The SFDA drug registration requirements in Saudi Arabia had evolved significantly during the past decade, especially in the submission particulars. It gradually transitioned from the paper format into eCTD online submission.

This allowed the regulatory professionals to spend less time on paperwork to put more focus on the scientific side, which is getting more advanced and thorough every day.

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 with developing a regulatory strategy. It is imperative to provide clarity on the expected impact on the business; hence, an accurate company decision.

Since the registration requirements are part of the regulatory strategy, it will eventually contribute to the progress of the project with a reliable and effective plan. 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. Not to mention business due diligence, which goes further off the drug file. Therefore, what we provide here is just to enable the primary market researchers to weigh the depth and length of the process.

In this direction, we segmented the requirements into the following sections to simplify such interconnected processes:

Drug Registration Guidelines

According to the drug type, we included in the below tables 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

Required 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.

Required 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)

The drug application that meets the SFDA conditions for priority review would receive a great reduction in the approval timelines. Companies might need to apply for this expedited procedure before the application submission. It is applicable for certain types of applications, for example, the first generic drug application.

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 (SFDA Sourced), you can see how the dossier submissinn process untill it reaches the assessment stage.

SFDA drug registration process

Validation

SFDA eCTD Validation Criteria

Upon reception of the dossier, SFDA performs an electronic validation on the compiled eCTD according to the GCC requirements. Some valid eCTD dossiers could be rejected at this stage for other errors such as invalid dossier sequence numbers or envelope data.

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 in the following :

  • Application type & fees
  • MAH/Manufacturing site status.
  • Active Pharmaceutical Ingredient (API)
  • Finished Pharmaceutical Product (FPP)
  • Clinical Data
  • Safety data (SPC/PIL)

Approval Timelines

  • New human drug:
    • Registered in SRA: 280 working days.
    • Not registered in SRA: 405 working days
  • Generic human drug: 155 working days
  • New Veterinary drug:
    • Registered in SRA: 260 working days.
    • Not registered in SRA: 385 working days
  • Generic Veterinary drug: 165 working days
  • Herbal & Health products: 95 working days.

Priority Review

SFDA verification & abridged registration

These are two accelerated registration procedures available in the SFDA for the new innovative drugs that are already registered in the FDA, EMA, or both. There are many conditions to meet to be able to apply for these procedures and they are time-consuming if not planned for as early as possible. Learn more about SFDA verification and abridged registration.

SFDA Drug Evaluation & Approval Process

Understanding the drug application 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 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:

Quality Evaluation

  • 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)

Testing

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

Inspection

This department is responsible for the evaluation, GMP certification, and manufacturer registration. They issue GMP certificates for local sites and approves foreign manufacturers after performing a GMP inspection visit. Some sites could be approved without an actual visit if they meet certain specifications. The process of manufacturing site registration is performed in parallel with drug product registration.

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.

Life Cycle Management

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.

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.

Read More

Stability Studies Requirements in SFDA

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top