In February 2017, the Saudi Food and Drug Authority (SFDA) announced two new accelerated pathways for drug registration applications, the Verification and Abridged pathways. that will enhance a fatser access to medicines in Saudi Arabia. Their objective is to ensure fast patient access to new medicinal products.

These two expedited pathways are reliance review procedures that enable rapid access to the Saudi market if a drug is already approved by specific reference countries/authorities, which are the European Medicines Agency (EMA), the Food and Drug Administration (FDA), or the United States Department of Agriculture (USDA).

These two application pathways are faster than the priority review pathway, and they are also applicable to variation applications.

Verification Registration

Drug registration by verification is the shortest route to SFDA approval and is available for newly approved and marketed drugs in both the EMA and the FDA. The targeted SFDA review timeline is only 30 working days and is applicable for:

New human medicinal products that are approved and marketed by both the EMA & FDA.
New veterinary products that are approved and marketed by both the EMA & FDA
Biological veterinary products approved and marketed by the USDA.
Approved in the reference countries within the past 2 years.

Abridged Registration

The abridged procedure requires approval from only one of the two reference agencies, enabling companies to apply swiftly in Saudi Arabia immediately after obtaining EMA or FDA approval. It has a targeted review timeline of 60 working days and is applicable for:

New human and medicinal products that are approved and marketed by either the EMA or the FDA.
New veterinary products that are approved and marketed by either the EMA or the FDA.
Biological veterinary products that are approved and marketed by the USDA.
Approved in the reference countries within the past 2 years.
Type II variation applications for new chemical entities and biologics of human and veterinary medicines.

If the product was approved via the standard registration pathway, the abridged pathway for variations may be considered.

Variation

Applicants must consistently use the same reference agency throughout the product’s lifecycle. For any variation requests, all supporting documentation should align with approvals issued by the selected reference agency.

For example, if the product is registered through an abridged pathway based on an EMA decision, all future variations should be supported by EMA approvals. Documentation from other agencies, such as the FDA, will not be accepted.

Sameness of Product

The application should have identical essential characteristics, including quantitative and qualitative parameters, manufacturing process, safety, and efficacy. The impact of any potential and justified differences should be assessed by the Marketing Authorization Holder (MAH) and SFDA to determine the possibility of using the reference agency’s assessment or decision.

Execlusions

Applications of blood products, advanced therapy medicinal products, and veterinary vaccines are excluded from the Verification and Abridged regulatory pathways. They are also not applicable for generic drug applications.

Requirements

To comply with the SFDA requirements for these two procedures, companies must begin preparation as early as possible, as there are specific requirements, such as localized packaging and other dossier criteria. The submitted file must include the following:

Modules 2, 3, 4, and 5 as submitted to the selected reference agency, with the same submitted clinical trial data,
Complete clinical and quality assessment report from the reference agency.
In case of variation, an approval letter from the Reference agency.
Required Module 1 parts for Saudi Arabia such as price certificate, labeling information, and appointed Saudi QPPV.
Stability studies in accordance with the Guidelines for Stability Testing.
Other minor supporting documents upon the SFDA’s request.
Dossier in electronic Common Technical Document (eCTD) for human Drugs and veterinary Non-eCTD electronic submission (vNees) or Common Technical Document (CTD) for Veterinary products.

Exceptions

It is important to note that some products may be eligible for Abridged and Verification pathways even if they don’t meet all the SFDA required criteria. We invite you to evaluate your product eligibility with one of our experts at PharmaKnowl, who has several annual submissions of such designations and can ensure you are not leaving any chances on the table. Feel free to request an exploratory meeting or Contact Us for more details.

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