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SFDA Drug Registration Requirements

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The Author

Mohammed Jobran

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

In this post, we aim to outline the SFDA drug registration requirements and approval process to receive marketing approval. It should provide high-level coverage of the drug application types and their requirements to help you draw the big picture of the SFDA drug registration process. We believe it is essential, especially for those new to Saudi pharmaceuticals.

If you are unsure if your product is a drug, you can refer to our comprehensive post that details the SFDA Product Registration process for other types of products. You can also refer to our other dedicated posts on Medical Device Registration, Food Supplements Registration, and Cosmetics Registration in Saudi Arabia.

Introduction

The Saudi Food and Drug Authority (SFDA) regulates pharmaceutical products in Saudi Arabia and determines drug registration requirements and post-marketing obligations. These requirements have evolved significantly since 2009, when the ICH guidelines were adopted. The submission particulars have significantly transitioned from the paper format to CTD, then NEES, and then to the current eCTD dossier. Therefore, to help you prepare the regulatory requirements, it is also essential to know what you will encounter during the registration process.

Planning For Drug Registration

When preparing for an SFDA registration project, the best practice is to start by developing a regulatory strategy, particularly for new companies to the Saudi market. An excellent regulatory strategy is necessary for 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 make its execution more effective and reliable. Please read our article How to Develop a Regulatory Strategy for the Saudi Market.

Drug Registration Requirements

The most common question I receive is, “What are the SFDA registration requirements?” This question is tricky to respond to by providing a confined checklist. Every required document has its specific compliance measures, let alone the needed comprehensive due diligence that goes beyond the drug file.

Therefore, the information provided here is 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

Guidelines

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 one 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
  • Guidance for Presenting PIL and Labeling Information on 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, 5.3.1.2, 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: Many variables exist for Herbal, health, and veterinary dossiers based on product attributes and ingredients.

Dossier Format

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

Module 1 Requirements

  • 1.0 Cover letter
  • 1.1 Comprehensive table of content
  • 1.2 Application Form
  • 1.3 Product Information
    • 1.3.1 Summary of Product Characteristics (SPC)
    • 1.3.2 Labeling
    • 1.3.3 Patient information leaflet (PIL)
    • 1.3.3.1 Arabic leaflet
    • 1.3.3.2 English leaflet
    • 1.3.4 Artwork (Mock-ups)
    • 1.3.5 Samples
  • 1.4 Information on the experts
    • 1.4.1 Quality
    • 1.4.2 Non-clinical
    • 1.4.3 Clinical
  • 1.5 Environmental Risk Assessment
    • 1.5.1 Non-Genetically Modified Organism (Non-GMO)
    • 1.5.2 GMO
  • 1.6 Pharmacovigilance
    • 1.6.1 Pharmacovigilance System
    • 1.6.2 Risk Management Plan
  • 1.7 Certificates and Documents
    • 1.7.1 GMP Certificate
    • 1.7.2 CPP or Free-sales
    • 1.7.3 Certificate of Analysis – Drug Substance / Finished Product
    • 1.7.4 Certificate of analysis – Excipients
    • 1.7.5 Alcohol-content declaration
    • 1.7.6 Pork- content declaration
    • 1.7.7 Certificate of Suitability for TSE
    • 1.7.8 The diluents and colouring agents in the product formula
    • 1.7.9 Patent Information
    • 1.7.10 Letter of access or acknowledgement to DMF
  • 1.8 Pricing
    • 1.8.1 Price list
    • 1.8.2 Other documents related
  • 1.9 Responses to questions

Drug Application

The SFDA drug registration application must 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 Products (Food Supplements)
  • Veterinary Product
    • New Drug
    • Biological Drug
    • Generic (Multisource) Drug
    • Herbal Product
    • Health product

Application Fees

You may refer to our detailed post: SFDA Fees.

Submission

The following image shows the application submission process, which involves two layers of validations, which 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.

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 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

The drug sector has different assessment timelines depending on the type of application and whether it is registered in a reference country (stringent regulatory authority). For details, read SFDA timelines.

Review and Approval Process

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

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

Evaluation Department

Quality

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

Benefit & Risk Evaluation

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

Inspection

This department is responsible for evaluating, inspecting, and granting the SFDA GMP approval. Applicants should expect mandatory GMP licensing for all drug, health, herbal, and veterinary manufacturers. This includes 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 that it will be performed on the first batch arriving in 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 drug registration stage. This evaluation stage will not be parallel to the assessments mentioned above. 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 and ask the applicant to accept or appeal.

Registration Committee

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

Drug 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 five 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, labelling (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 a 40% reduction on the standard approval timelines.
  • Orphan Drug Designation (ODD)
    • 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 to FDA or EMA-approved drugs.
    • Provides the most significant reduction in timelines.
  • Conditional Approval
    • Applicable for products that address unmet medical needs
    • Same standards SFDA timelines.

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 scheduled updates on the registered information. These are known as variation applications, which have their procedure and requirements. Whether it’s administrative or technical information changes, they must all be approved by the SFDA before marketing. Read more: SFDA Variation Guidelines Overview.

Drug License Renewal

Companies must maintain their product license validity by submitting a renewal application before the expiry of the SFDA certificate. This is allowed six months before the expiry date.

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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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