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Updated Guidance for Priority Review ofProduct Registration - Saudi Food & Drug Authority

Priority Review indicates that the review process of the application will be expedited by the concerned departments. However, the designation of a product as priority review does not alter any of the scientific standards and quality of evidence required for approval.

Saudi Food & Drug Authority updated this guidance last week which has been developed to assist applicants in the preparation and submission of priority review applications.

This guidance is intended to facilitate and expedite the review of the human drugs that are intended to treat serious or life threatening conditions, address unmet medical need and first generic / biosimilar for the innovated product. It is also intended for veterinary drugs according to the criteria outlined in these guidelines.

This guidance provides criteria for the designation and process of submission of priority review applications and the guideline details about

  1. Criteria for Qualifying for Priority Review Designation: New Drug & Biological, Generic or biosimilar, Availability & Veterinary products

  2. Process for Designating a Drug for the Priority Review

  3. Application form & the Application Review Timeline

Click this LINK for more detailed information about this guideline.


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