Snapshot

The Fast track procedure pathway has been developed by the Egyptian Drug Authority of Egypt.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Canada Denmark Finland France Germany Iceland Ireland Italy Japan Luxembourg Netherlands New Zealand Norway Portugal Spain Sweden Switzerland United Kingdom United States

HUMAN DRUG REGISTRATION WORKFLOW OVERVIEW: (1) Front Office: Applications; Checklists = 15 Working Days; (2) Receiving the hard file = 30 Working Days; (3) Pricing = 60 Working Days