Snapshot

The Abridged Procedure pathway has been developed by the Saudi Food and Drug Authority of Saudi Arabia.

This pathway can be used where Applicable for marketing authorization of both Human and Veterinary medicinal products for the following products: • New Products (New Chemical Entity). • Biological Products (excluding biosimilars, blood products, vaccines and advanced therapy medicinal products “for human”)..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA United States

60 working days. NB: The review clock will not begin until the product has been accepted to be priority reviewed.