Verification and Abridged Pathways Guide

​​1.1. Objective 

The Drug Sector at the Saudi Food & Drug Authority (SFDA) has developed this document to help the applicants on how to proceed with the registration and variation applications through verification or abridged pathways.

1.2. Background

The verification or abridged pathways are options meant to facilitate the registration of products or variations that are already approved by the United States (US) Food and Drug Administration (FDA), US Department of Agriculture (USDA), and/or European Medicines Agency (EMA).

1.3. Scope

The Verification and Abridged regulatory pathways apply to marketing authorization applications for new chemical entities and biologics of human and veterinary medicines. 

The abridged pathway also applies to type II variation applications for new chemical entities and biologics of human and veterinary medicines.

Applications of blood products, advanced therapy medicinal products, and veterinary vaccines are excluded from the Verification and Abridged regulatory pathways.

1.4. Related guidelines

This document should be read in conjunction with the following Drug Sector documents:

• Regulatory Framework for Drug Approvals.

• Guidance for Submission.

• Guideline for Variation Requirements

• Verification pathway: The following drug regulatory agencies have approved and marketed the product:

o For human medicinal products: EMA and FDA.

o For veterinary medicinal products: EMA and FDA (for new veterinary products), USDA (for biological veterinary products).

• Abridged pathway: Either of the following drug regulatory agencies has approved and marketed the product and/or post-approval changes;

o For human medicinal products: EMA or FDA.

o For veterinary medicinal products: EMA or FDA (for new veterinary products), USDA (for biological veterinary products).

• Sameness of product: Compared to the reference agency, the submitted product application shall have identical essential characteristics. All relevant aspects of the product, including those related to the quality of the product and its components, should be considered to confirm that the product is the same or sufficiently similar (e.g., same qualitative and quantitative composition, strength, pharmaceutical form, intended use, manufacturing process, suppliers of active pharmaceutical ingredients, quality of all excipients). Additionally, the results of supporting studies of safety, efficacy, quality, indications, and conditions of use should be the same. The impact of potential and justified differences should be assessed by the marketing authorization holder and the SFDA to determining the possibility of using the reference agency’s assessments or decisions.​

• The application must be submitted to the SFDA within two years from the date of approval by the reference agency. 

• The product does not need a more stringent assessment as a result of different local disease patterns and/or medical practices.

• The product and its intended use (indications, dosage information, and patient groups (for human product) or target animal species (for veterinary product)) has not been rejected, withdrawn, suspended by any drug regulatory agency for safety or efficacy reasons.

• The manufacturer should be located in one of the following countries:

USA, UK, Canada, Australia, Japan, Switzerland, Germany, France, Ireland, Italy, Spain, Portugal, Finland, Sweden, Norway, Denmark, Belgium, Netherlands, Austria or Singapore. 

The level of manufacturing activity represents: 

o For Biologicals: Biological Substance and Finished product. 

o For Pharmaceuticals: Finished Product (bulk) and Primary Packaging.​

​4.1. Registration 

4.1.1. A complete file:

• For human products: according to Data Requirements for Human Drugs Submission, the eCTD submission should be the same as the reference drug regulatory agency (FDA or EMA) for Modules (2-5).

• For veterinary products: according to the Data Requirements for Veterinary Medicinal Products, the submission (vNees or CTD) should be the same as the reference drug regulatory agency (FDA, USDA or EMA).

4.1.2. In Module 1 (for human products) or Part 1 (for veterinary products) and under Additional Data Section, applicant must add the following:

• In the cover letter: submit the requested pathway of registration and the reference(s) date of approval.

• A declaration letter issued by the applicant stating that all aspects of the drug product’s quality, including but not limited to, the formulation, manufacturing site(s), release and shelf life specifications, primary packaging and active pharmaceutical ingredient(s) source are identical to that currently approved by FDA / USDA and/or EMA at the time of submission. However, a different type of the container closure system (e.g. Alu/Alu blister vs. HDPE bottle) may be proposed to meet the stability requirements.

• Complete assessment report and other relevant supporting documents from the reference drug regulatory agency according to the following: 

- Verification process: the following/documents are required from both reference drug regulatory agencies:

i. Complete clinical and quality assessment report along with if applicable assessment on the Question & Answer documents between the Sponsor and Agency and all annexes.

ii. Assessment reports and/or documents pertaining to post-approval variations (if applicable). 

iii. The submitted assessment reports should be unredacted or unedited, when possible, and should include details of imposed licensing conditions, final product labelling, chemistry and clinical review, and other information concerning the product’s approval. Redacted or edited reports might be acceptable if not related to the quality, safety or efficacy of the product. Trade secrets, confidential commercial and financial information, can be excluded from the submission. Reports obtained from the public domain are deemed to be unacceptable. 

- Abridged process: It is similar to verification, but it requires only one of the two regulatory agencies referenced.

• For the inspection requirements; if the manufacturer is not registered in SFDA, then the company has to pay the fees and submit the following:

- Valid GMP certificates from the local authority and other international authorities

- A copy of Site Master File (SMF),

- List of all products that manufactured at the site and supplied to Saudi Arabia,

- Last Inspection Report - in English - from the local authority.

- If available, last Inspection Report - in English - from other international authorities.

4.1.3. Stability studies according to the Guidelines for Stability Testing.

If such studies are not available, the following requirements should be submitted:

i. A commitment letter to conduct stability studies according to the Guidelines for Stability Testing;

ii. An assurance letter must be provided stated that the applicant will report SFDA immediately if there are any Out of Specification (OOS) results

4.1.4. Price certificate (Form 16) .

4.1.5. Supporting documents on comparative safety and efficacy studies illustrating the added value from an economic perspective.

SFDA may request additional documentation not specifically outlined in this document, in order to adequately assess the safety, efficacy and quality of drug products.  SFDA is committed to ensuring that such requests are justifiable. 

4.2. Variation

4.2.1. Approval letter from reference agency.

4.2.2. Signed declaration of sameness of product must be provided including justifications for any potential differences.

4.2.3. A complete assessment report, unredacted and unedited, for the approved variation(s) by the reference agency.

4.2.4. Report that includes all questions and answers between the applicant and reference agency, including all annexes (unredacted/unedited).

​5.1. For registration 

Step 1: Online submission

i. The applicant should submit the application form through SDR system and pay the fees.

ii. Upload the product’s file.

iii. Request a designation through Designation.Drug@sfda.gov.sa

Step 2: Request a pre-designation meeting

If necessary, SFDA will request a meeting with the applicant to verify eligibility and ensure that the application meets all requirements:

i. The Regulatory Affairs staff will notify the applicant by email within five working days with the details of the meeting. 

ii. The applicant should submit the checklist (see Appendix) and send them to Designation.Drug@sfda.gov.sa 

iii. During the meeting, the Regulatory Affairs staff will extensively assess the product file according to the guidance and the checklist.

Step 3: Waiting for decision

• The applicant will receive the Drug Sector decision through Designation.Drug@sfda.gov.sa within ten working days;

• In case of non-eligibility, the application will be transferred to the other pathways (note: registration fees are non-refundable).  

5.2. For variation

Step 1: Online submission

i. The applicant should submit the application form for variation by Abridged pathway (see Appendix), upload it through the SDR system and pay the fees.

ii. Upload the product’s file.

Step 2: Business Validation

i. The product file will be validated to ensure that all information provided is according to the requirements and/or guidelines.

ii. In case of non-eligibility, the application will be proceeded according to the regular variation timeline.​

Refer to the Regulatory Framework for Drugs Approval on target processing timelines for Drug Sector's registration steps.

The performance targets start when the Drug Sector approves the requested pathway by email.

• The SFDA is not obligated to approve the application even if it receives approval by reference from a drug regulatory agency. 

• During evaluation and for safety, efficacy or quality concerns, the related departments might request to transfer the application to the regular pathway. However, SFDA commits to clarify the decisions for any case.

• Applicants are required to adhere to the chosen reference agency throughout the product's lifecycle. For all variation requests, applicants must submit supporting documentation that conforms to the approvals issued by the chosen reference agency. For example, if an abridged pathway registration is based on an EMA decision, all subsequent variation requests must also utilize the EMA as the reference agency. Supporting documentation from the FDA will not be accepted.

• SFDA reserves the right to reject the application if the applicant submits false or misleading information.

• Confidential information which submitted by the companies to support their registration application is protected and will not be shared by any means with other parties.​

​​This section includes answers of the most frequently asked questions about the verification and abridged:

8.1. Scope

- Will SFDA accept the product registration via the decentralized procedure in Europe?

EMA registration means centralized procedure.

​- What is the situation for products that are approved by Health Canada, PMDA, Swiss Medic or TGA?

Only FDA, USDA and EMA are considered as reference agencies.

- If the product is generic and it is lifesaving, is it possible to apply through verification and abridged?

The registration by verification and abridged is accepted only for new products (NCE) and biological products. 

8.2. File submission

- What counts as proof of product registration?

For human products: Refer to the SFDA data requirements section 1.7.2 

For veterinary products: Refer to the data requirements for veterinary medicinal products section 1a42.

- If conditional approval granted by FDA, USDA/ EMA, can the company apply to SFDA by using such conditional approval?

Yes, and the applicant has to submit evidence of approval. 

- What are the file’s requirements to submit the product through verification and abridged process?

Refer to the requirements section.

- For products which their manufacturing sites are not registered at SFDA, does SFDA approve the product without site inspection? 

If the product manufacturing site is located in one of the countries mentioned in the Eligibility Criteria section, site inspection will not be a barrier for the product registration. SFDA will take the necessary actions to maintain the registration within the timeframe.

8.3. General

- If company could not perform stability data on GCC zone according to the SFDA guidelines on stability testing, can SFDA approve the data on Zone II?

The following should be submitted:

• A commitment letter to conduct stability studies according to the SFDA Guidelines for Stability Testing;

• Assurance should be given that any out of specification results will be reported immediately to the SFDA.

- For verification, what is the situation in case if there are any differences between Europe and US approved product (e.g. differences in approved indications, product label)? 

In this case, SFDA will follow the applicant’s chosen primary reference agency.

- In case of differences for example: manufacturing site, release and shelf life specifications, primary packaging and API source; will the SFDA accept to register the product through verification and abridged procedure?

The submitted file must include a declaration letter stating that all aspects of the drug product’s quality, including but not limited to the formulation, manufacturing site(s), release and shelf life specifications, primary packaging and API source are identical to that currently approved by the chosen reference drug regulatory agency.

- Is the current pricing rules part of the verification and abridged?

Yes, it is.

- Is the product testing part of the verification and abridged?

Yes, it is and refer to the Regulatory Framework for Drug Approvals.

- Will SFDA review the Arabic translation of leaflet, label and carton during the registration process?

Yes, it will.​

​9.1. Request for pre-designation meeting

Applicants must use this form to send a Designation request by email to Designation.Drug@sfda.gov.sa​ being titled with “Designation request for Verification or Abridged”

​

9.2. Application form for variation 

The applicant shall apply through SDR system to fill the application form and pay the fees.  

1. General information 

10.1. Checklist for Verification

10.2. Checkli st for Abridged