Under the Saudi Food and Drug Authority (SFDA) appeal process, manufacturers and applicants have the right to file a formal objection whenever the SFDA takes action against the submitted applications, such as rejecting a drug registration application or not issuing a favorable pricing decision.

This article discusses the appeal process and steps, types of cases that qualify for appeals, and strategic steps that maximize the possibility of success in an appeal by properly organizing a submission.

What is an SFDA Appeal?

An appeal is a request that the organizations or their agents submit to the SFDA to review its regulatory decision. It may be against the rejection of a drug registration application, any adverse decision on pricing, or, for that matter, any decision taken by an internal committee of the SFDA.

When Should You Consider Filing an Appeal?

SFDA policy allows appeals in the following cases:

Rejection of drug registration decisions
Pricing decision
De-registration decisions
Permanent Cessation
GMP and product License cancellation or Suspension
Regulatory refusals of product renewals

An adverse decision regarding a product’s marketability may impact its status or market access.

SFDA Appeal Steps

Step	Action	Details
1	Review Rejection Decision	Study the SFDA rejection letter and note the date of notification. This notification is received via email through the electronic Saudi Drug Registration (eSDR) system
2	Prepare First Appeal	The first appeal should be ready for submission within 60 calendar days of the date of notification.
3	Compile Required Documents	1) Upload the document(s) containing response(s) as per electronic Common Technical Document (eCTD)/ Common Technical Document (CTD)/ Veterinary Non-eCTD electronic Submission (VNeeS) requirements. 2) Include the decision with justifications under the “Response to Question section.” 3) Complete and include the appeal request form (appropriate one). Cover letter, price certificate, and scientific/economic/logistic justifications for pricing appeals.
4	Submit the Appeal to SFDA	Submit the appeal to SFDA along with the documents to the relevant department at SFDA. Business validation occurs within 5 days.
5	Address Deficiencies	If the SFDA issues a notice about missing or incomplete documentation. It must be fixed within the balance of the appeal window after such notification, or within 5 days after the expiry of that window, whichever is earlier.
6	Respond to Inquiries	If SFDA raises inquiries or requests further information, respond within 10 days; otherwise, the request will be considered rejected.
7	Request Meeting (Optional)	After filing the appeal and before a decision is rendered, you may request a meeting with the SFDA.
8	Await SFDA Decision	The SFDA’s decision, accompanied by justifications, will be provided within 60 days of receiving a complete appeal.
9	Prepare a Second Appeal (if needed)	If the first appeal is rejected or not answered, file for a second appeal within 30 days of notification of the decision on the first appeal or the expiration of the response time. Pay the required fees and attach the first appeal decision (if any).
10	Submit Second Appeal	The second appeal will follow the same process and documentation standards. SFDA will issue a final decision within 30 days.
11	Request a meeting	A company or its agent can request a meeting with SFDA before submitting the appeal.
12	Comply with Final Decision	The decision of the second appeal shall be final. If it is negative, the companies may request permanent product cessation.

Appeal Strategy

A clear strategy minimizes the risk of rejection and optimizes your chances of getting SFDA approval. The following best practices will help you create a stronger and more effective submission.

Gap Review

Review the application against the latest templates and technical guidance provided by SFDA to easily identify gaps in information that may be missing, old formats used, or misaligned modules, which otherwise would prompt a refusal.

Submission Data Organization

Correct eCTD sequence referencing and the availability of all local documents, such as module 1, will ensure no ambiguity during review.

Regulatory Updates Monitoring

Monitor the latest updates from SFDA, particularly on document formatting, safety reporting, and Arabic content requirements. Minor changes can lead to invalidation and, hence, delay in review.

Involve Local Regulatory Support

Work with a local expert who will help you ensure the submission meets every expectation. From formatting to timelines, experience support reduces errors and increases the chances of getting approval.

Appeal Support

PharmaKnowl guides manufacturers from dossier resolution to filing an appeal with the SFDA, including all steps in between, such as drafting Request For Information (RFI) responses.
Reach out to our team today for more information.

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