Regulatory Framework for Drugs Approval

The Drug Sector in Saudi Food & Drug Authority (SFDA) has developed this administrative document to provide assistance for stakeholders on how to submit applications for various types of drug products and the procedure to authorize the applications.

Besides the Market Authorization Application (MAA) of various types of drug products, it also describes variations applications and renewal of MAA. Time-frame for processing applications to marketing the product in Saudi Arabia are also included in this document. ​​

This framework applicable to all types of drug product submitted for registration, variation or renewal.​​

The MAA of pharmaceutical product will be subjected to the followings processes:

3.1. Submission 

The process of submitting a new MAA consists of two steps:

3.1.1. Online submission 

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

2. Upload the product file; the components of the file shall follow the requirements and guidelines published on SFDA website.

       3.1.2. Validation

The product file will be validated in technical and business bases to ensure the applicant fulfills the requirement. The validation involves two steps:   

              3.1.2.1. Technical validation

SDR system will validate the submission automatically after the company upload the file on the SDR portal. The validation’s result will be sent by email through SDR system to the applicant. 

              3.1.2.2. Business validation

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

       2. If any information is missing or incorrect, an electronic inquiry will be forwarded to the applicant through the SDR system. The applicant will be given an opportunity to complete the file within 30 working days. 

       3. The completed file will proceed to the next steps for Assessment (section 3.2).

The registration request will be rejected in the following cases:

       • No response from the applicant within 30 working days.

       • If the applicant provided unsatisfied requirements or did not include the required documents or justification for the absence of a document according to SFDA guidelines.

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3.2. Assessment 

The MAA for different drug submission types subject to the following processes:

3.2.1. Evaluation / Inspection

1. The RA will distribute the registration request to the relevant departments to assess quality, safety and efficacy;

              • For Inspection: the department will check the approval of manufacturing line; if not approved: 

                     o Visit will be scheduled for inspection depending on the time available for both inspectors and the company.

                     o After the visit, the inspection report will be sent to the company (please, refer to the Good Manufacturing Practice for Medicinal product).

2. If more information or clarification is required, an electronic inquiry will be posted through SDR system as one wave for evaluation and inspection. A response should be received within 60 working days.

3. Once the evaluation and inspection are completed, the registration request will be forwarded to Pricing (section 3.3)

3.2.2. Testing

1. The registration request will be forwarded to the SFDA Central Laboratories.

2. If more information or clarification is required, an electronic inquiry will be posted through SDR system.

Note: Testing will not delay the registration of a product.

3.3. Pricing 

1. The Pricing Department will review product’s price according to the “SFDA's pricing rules”.

2. If more information or clarification is required, an electronic inquiry will be posted through SDR system. A response should be received within 60 working days.

3. The product’s price will be forwarded to Registration Committee (section 3.4).

Important Note: 

The applicant will have a maximum of four (4) waves for Assessment and pricing, and the SFDA has the right to take a decision at any time during the assessment step, regardless of the wave number.

The registration request will be rejected in the following cases:

       • No response from the applicant within 60 working days.

       • If the applicant provided unsatisfied requirements or did not include the required documents or justification for the absence of a document according to SFDA guidelines

3.4. Product licensing 

1. The Registration Committee will review the registration request for approval, rejection or ask for further information (if needed).

2. The SFDA CEO will approve the meeting minutes.

3. For approved registration request, the applicant will be notified through SDR system to issue the MA. 

Appeal Process:

The applicant has the right to appeal against any decision within 60 calendar days  as of the date on which the company or its agent is notified of the decision., for more information refer to The Policy of Appeal to Drug Sector Decisions.

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Figure 2  schematic figure showing the different levels for getting a marketing authorization (section 3.2, 3.3 and 3.4)

3.5. Registration performance targets

       • The performance target in any step will STOP if a clarification or information is needed from the applicant, and resume after receiving the response.

       • All days are considered as working days.

       • Total Performance Target calculated without the Business Validation for all pathways

3.5.1. Regular review pathway

3.5.2. Priority review pathway (40% reduction) :​

3.5.3. Abridged pathway :

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[2] Refer to the Guidance for Priority Review of Product Registration

 [3] Refer to the Registration According to Abridge Pathway

​The Breakthrough Medicine Program is intended to expedite the development and review of new drugs that can treat serious or life-threatening conditions where there is a lack of effective treatment options. Participation in the program is voluntary, and it involves early dialogue between drug developers and SFDA to optimize development plans and accelerate evaluation. The goal is to ensure that promising drugs are made available as soon as possible, provided that their benefits outweigh their risks.

For more information regarding the criteria and procedure to submit the request please refer to Guidance on Breakthrough Medicine Program.​

Any changes on a registered product has to be submitted to the SFDA as a Variation of MAA. The variations are classified into two main categories :

A. Minor variations

    • Type IA: Such minor variations do not require prior approval before implementation (“Do and Tell” procedure). Type IAIN variations should be submitted immediately, within 14 days following implementation. Other type IA variations, however, can be compiled in a single variation application, to be submitted to the SFDA no later than January 31st of each year.

    • Type IB: minor variations that must be submitted to the SFDA by MAH before implementation, but do not require a formal approval. However, the MAH must wait a period of 60 working days to ensure that the application is deemed acceptable by the SFDA before implementing the change (“Tell, Wait and Do” procedure).

B. Major variations

    • Type II: major variations in which there might be a significant impact on the Quality, Safety or Efficacy of a pharmaceutical product and require prior approval before implementation.

The variation request subjects to the following process: 

5.1. Submission 

The process of submitting a variation of MAA consists of two steps:

5.1.1. Online submission

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

    2. Upload the product file; The components of the file shall follow the requirements and guidelines published on SFDA website

For applications made via the new SDR system, three parallel variation applications can be submitted at a time, each includes administrative, quality or safety variations. 

5.1.2. Business Validation

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

    2. If any information is missing or incorrect, an electronic inquiry will be forwarded to the applicant through the SDR system. The applicant will be given an opportunity to complete the file within 30 working days.

    3. The completed file will proceed to the next step for Assessment (section 4.2).

The variation request will be rejected in the following cases:

        • No response from the applicant within 30 working days.

        • If the applicant chose the wrong variation type according to the Guidelines for Variation Requirements, provided unsatisfied requirements, or did not include the required documents or justification for the absence of a document according to relevant SFDA guidelines.

5.2. Assessment 

Depending on the type of variation, one or more department may review the variation application. 

5.2.1. Evaluation / Inspection:

    1. The variation request will be distributed to the relevant related department – as needed;

        • For the inspection related requests: the department will check the approval of manufacturing line, if not approved: 

            o Visit will be scheduled for inspection depending on the time available for both inspectors and the company.

            o After the visit, the inspection report will be sent to the company (please, refer to the guidance of Good Manufacturing Practice for Medicinal product).

    2. If more information or clarification is required, an electronic inquiry will be posted through SDR system. The response should be received within 60 working days. 

    3. Reports (recommendation for approval or rejection) will be collected by the RA.

    4. The reports will be forwarded (if needed) to pricing (section 4.3) and registration committee (section 4.4) depending on the type of variation.

5.3. Pricing 

    1. The Pricing Department handles all variation requests that require pricing review according to “SFDA’s pricing rules”.

    2. If more information or clarification is required, an electronic Inquiry will be posted through SDR system. A response should be received within 60 working days.

    3. The approved price will be forwarded to the Registration Committee (section 4.4).

Important Note: 

The applicant will have a maximum of three (3) waves for Assessment, and pricing, and the SFDA has the right to take a decision at any time during the assessment step, regardless of the wave number.

The variation request will be rejected in the following cases:

    • No response from the applicant within 60 working days.

    • If the applicant provided unsatisfied response/ requirements or did not include the required documents or justification for the absence of a document according to relevant SFDA guidelines

5.4. Product Licensing 

• For all variation types except variation affecting product price:

    1. The RA will approve the final report.

    2. Notify the applicant through SDR system.

• For variation affecting product price:

    1. The Registration Committee will review the variation request for approval, rejection or ask for further information (if needed).

    2. The SFDA CEO will approve the meeting minutes.

    3. For approved variation request, the applicant will be notified through SDR system. 

General variation notes:

    • For applications made via the new SDR system; after the completion of an application of a particular category (by approval or rejection), another application of the same category can be submitted.

    • For application includes more than one type of variation, the longest duration in total performance target will be considered. For example: application includes type 1B and type II, the total performance target for the application is 100 working days.

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Figure 3 Schematic figure showing the workflow of Variation

5.5. Variation performance targets:

   • The performance target in any step will STOP if a clarification or information is needed from the applicant, and resume after receiving the response.

   • All days below are considered as working days.

• Total Performance Target calculated without the Business Validation for all types of variations.​

​An applicant shall submit a renewal request every five years . It is possible to request for renewal within six months of the certificate expiry. 

As most of the registered drugs have went through at least one renewal process or have been registered through SDR system; therefore, the renewal process is shorter as follows:

6.1. Submission 

The process of submitting a renewal of MA consists of two steps:

    6.1.1. Online submission:

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

        2. Upload the renewal file; The components of the file shall follow the requirements and guidelines published on SFDA website.

    6.1.2. Business Validation:

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

        2. If any information is missing or incorrect, an electronic Inquiry will be forwarded to the applicant through SDR system. The applicant will be given an opportunity to complete the file within 30 working days. 

        3. The completed file will proceed to the Pricing Department (section 5.2).

The renewal request will be rejected in the following cases:

• No response from the applicant within 30 working days.

• Failure to provide acceptable clarifications.

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6.2. Pricing 

1. The Pricing Department will review the price according to the “SFDA's pricing rules”.

2. If more information or clarification is required, an electronic inquiry will be posted through SDR system. A response should be received within 60 working days.

3. The approved price will be forwarded to the product licensing (section 5.3).

The renewal request will be rejected in the following cases:

• No response from the applicant within 60 working days.

• Failure to provide acceptable clarifications.

6.3. Product Licensing 

1. The RA will issue the renewal of MA. 

2. The applicant will be notified through SDR system.

Important Note: 

The rejected renewal applications obligate the applicant to submit a new one.

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Appeal Process:

The applicant has the right to appeal within 60 calendar days of the SFDA's final decision, for more information refer to The Policy of Appeal to Drug Sector Decisions.

Figure 4 Schematic figure showing the renewal process of a marketing authorization

6.4.   Renewal performance targets:

• • The performance target in any step will STOP if a clarification or information is needed from the applicant, and resume after receiving the response.

• • All days below are considered as working days.

• • Total Performance Target calculated without the Business Validation.​
  

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[6] Performance targets for each step are provided at the end of this part (section 5.4)

[7] For Human Medicinal products refer to the GCC Data Requirements for the Renewal of MA, For Veterinary Medicinal products refer to the Data Requirements for Renewal the MA of Veterinary Medicinal Products ​​