The Saudi Food and Drug Authority (SFDA) has updated its Policy of Appeal to Drug Sector Decisions to Version 1.3, strengthening transparency and providing clear procedures for companies wishing to appeal regulatory decisions.

Purpose of the Policy

This policy aims to guide pharmaceutical, herbal, and veterinary manufacturers and their agents in Saudi Arabia through the process of appealing decisions issued by the SFDA’s Drug Sector or requesting a reevaluation of product prices.

Scope of the Policy

• Registration decisions – including rejections
• Deregistration decisions – product removals
• Pricing decisions – including price increases, decreases, or confirmations
• Clinical studies decisions – approvals, rejections, or cancellations

Key Definitions

• Appeal: The right to contest a Drug Sector decision. First Appeal: Must be submitted within 60 days of the original decision. Second Appeal: May be submitted within 30 days after the first appeal decision.
• Price Reconsideration: Companies may request a reevaluation of a product’s price three years after the last price decision.
• Price-Based Decision: Any SFDA committee’s decision to increase, decrease, or maintain a product’s price.

General Principles

• Submitting an appeal does not exempt the company from its obligations, including product supply.
• Appeals must be supported by documented evidence and cannot be used to complete missing registration data.
• Requests are evaluated technically, and insufficient justifications may lead to rejection.
• For products with Gulf-wide standardized prices, price appeals must be submitted first to the Gulf Health Council.
• Companies may request a meeting with SFDA after submitting an appeal.

Regulatory Requirements

• A cover letter with justifications.
• Relevant technical documents (eCTD/CTD/VNeeS format).
• Completed appeal forms (technical decision, pricing, clinical trial, or inspection appeal forms as applicable).
• Evidence such as clinical data, economic studies, market share data, or product availability data.
• Payment of applicable fees for each package under appeal.

Appeal Process & Timelines

• Submission & Validation: SFDA verifies completeness within 5 days.
• Correction Period: If requirements are missing, companies have up to 5 days (or until the appeal deadline) to complete the file.
• Study Phase: SFDA reviews the appeal within 30–60 days depending on the type of request.
• Response to Inquiries: Companies must respond within 10 days to SFDA inquiries; failure to respond leads to rejection.

What’s New in Version 1.3

• Expanded scope to include pharmaceutical, herbal, and veterinary plants/products.
• Updated definitions and added a new term: “Price-based decision.”
• Revised general concepts and added clarifications on Gulf Health Council submissions.
• Updated annexes and appeal forms for technical decisions, pricing, clinical trials, and inspection results.