Snapshot

The Priority Review pathway has been developed by the Saudi Food & Drug Authority of Saudi Arabia.

This pathway can be used where CRITERIA FOR QUALIFYING FOR PRIORITY REVIEW DESIGNATION. A. New Drug & Biological: The priority review process for New (i.e. product that includes new chemical entity and introduced by the innovator company or the partner) & Biological drug are intended for the treatment of a serious or life-threatening condition and/or demonstrates the potential to address unmet medical needs. 1. Serious or Life-Threatening Condition: Since the benefits of priority review designation apply to products for serious conditions as well as to products for life-threatening conditions, distinction between the two categories of conditions with regard to eligibility for priority review is unnecessary. Therefore, all references to serious conditions will include life-threatening conditions. 2. Demonstrating the Potential to Address Unmet Medical Needs: SFDA will determine whether the drug has a potential to address unmet medical needs and whether the drug development program is designed to evaluate this potential. B. Generic or biosimilar: - The priority review process for the generic drug is intended for the product considered the first generic to the innovative product that is already registered in SFDA. - The priority review process for the biosimilar drug is intended for the product considered the first biosimilar to the innovative product that already registered in SFDA or stringent regulatory authority. C. Availability: The priority review request for an unavailable drug will be evaluated according to the following criteria: 1. The product is included in one of the updated SFDA list for unregistered or unavailable products. 2. The alternative registered products don’t cover the local market needs. 3. The product is included in one of the updated national product mandatory lists that are published on local content and government procurement authority websites. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Process for Designating a Drug for the Priority Review: General procedures applicable to the submission of priority review designation request is described below: A. All criteria except first or second generic product 1. Request for priority review is sent to Drug sector prior to submission 2. Drug sector will respond to applicant within 15 working days 3. In case of request approval, decision will be send via SDR's email 4. The applicant should attach the approval email to the cover letter in module 1 5. Drug file is submitted 6. Priority review begins. Actual start and scheduling of review will depend on many factors, including staffing, workload, competing priorities and other factors. The review clock will not begin until the product has been accepted to be priority reviewed. The review clock will not begin until the product has been accepted to be priority reviewed. The total performance target is reduced by 40% of the normal registration process as described in “Regulatory Framework for Drug Approvals”.