Under the SFDA appeal process, manufacturers and applicants have the right to file a formal objection whenever the SFDA decides to take action, such as rejecting a drug registration application or issuing a negative pricing decision.
This article discusses steps to challenge decisions appropriately, types of cases that qualify for appeals, and strategic steps that maximize the possibility of success in an appeal by properly organizing a submission.
Table of contents
What is an SFDA Appeal?
An appeal is a request that individuals or organizations 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:
- Drug registration application rejections
- Pricing decision
- De Registration
- GMP License cancellation or Suspension
- Regulatory refusals of product variations or 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. |
| 2 | Prepare First Appeal | The first appeal should be ready to be submitted within 60 calendar days of the date of notification. |
| 3 | Compile Required Documents | 1) Attach the response file per eCTD/CTD/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 with documents to the relevant department at SFDA. Business validation occurs within 5 days. |
| 5 | Address Deficiencies | Suppose the SFDA issues a notice about missing or incomplete documentation. In that case, it must be fixed within the balance of an 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. |
| 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 or the expiration of the response time. Pay the required fees (if any) and attach the first appeal decision. |
| 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 | Comply with Final Decision | The decision of the second appeal shall be final. If it is negative, the companies may request permanent product deactivation or market withdrawal. |
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 spot gaps easily 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
Watch out for 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, encompassing all steps in between, including RFI response drafting.
Reach out to our team today for more information.
About the Author
Published by regulatory affairs team in PharmaKnowl, Riyadh office.
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