Snapshot

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

This pathway can be used where new chemical entities, biological products, .

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”.