The Saudi Food and Drug Authority (SFDA) has released an updated version (1.3) of its Policy of Appeal to Drug Sector Decisions, strengthening the framework for how companies can challenge regulatory outcomes and request price reconsiderations. The updated version, finalized in December 2024, expands the scope of appealable actions and refines requirements to ensure fairness, transparency, and efficiency in decision reviews.

What’s New in Version 1.3?

• Expanded Scope: The policy now applies to pharmaceutical, herbal, and veterinary manufacturers and their products in the following cases: Registration rejections, Deregistration decisions, Pricing decisions, Clinical study decisions
• Updated Definitions: Clearer definitions of appeal, price-based decision, and reconsideration of product price.
• General Concepts: Enhancements in procedural clarity, including limits on the number of appeals, conditions for reconsideration requests, and obligations of companies during the process.
• Annex Updates: Revised and expanded annexes with standard forms for technical appeals, price appeals, price reevaluations, clinical trial appeals, and inspection appeals.

Appeal & Reconsideration Rights

• Appeals: First appeal must be submitted within 60 days of receiving the decision. Second appeal may be submitted within 30 days of the first appeal decision. Appeals must be supported by documents and technical evidence.
• Price Reconsideration: Companies may request a reevaluation of product price three years after the last pricing decision. Requests will be evaluated within 90 days of completion.
• Special Provisions: If pricing is standardized at the Gulf Health Council level, requests must first be submitted regionally before reapplying to SFDA. Companies may request a meeting with SFDA after submitting an appeal. One-time extensions may be granted for responses if justified.

Regulatory Requirements

• Registration Decisions: Submit response files in eCTD/CTD/VNeeS format plus a completed technical appeal form.
• Pricing Decisions: Include cover letter, latest pricing decision, proposed price, supporting economic/clinical data, and completed appeal or reevaluation forms.
• Clinical Studies: Submit cover letter, decision copy, and completed clinical trial appeal form.
• Inspection Reports: Provide cover letter, inspection findings, and completed inspection appeal form.

Failure to meet requirements or respond within deadlines results in automatic rejection.

Appeal Process

• Appeals undergo business validation within 5 days of submission.
• Applicants must correct deficiencies within the specified appeal period (not exceeding 5 days if nearing deadline).
• Inquiries during the study phase must be answered within 10 days.
• Final decisions may result in appeal acceptance or rejection, communicated formally to the applicant.

Why This Matters

For pharmaceutical companies and regulatory affairs teams, the updated appeal policy provides a structured, transparent mechanism to challenge decisions and request
reconsiderations. By setting clear deadlines, documentation standards, and procedural safeguards, the SFDA ensures that regulatory outcomes remain fair, evidence-based, and consistent with international best practices.