Snapshot

The Biologics Reliance Pathways (decree 820/2016) pathway has been developed by the of Egypt.

This pathway can be used where Biologics.

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

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

see flow chart in references. According to the decree, there are three types of review procedures for biological products: ● Verification procedure: 30-day review process for products approved by both EMA and FDA. ● Abridged procedure: 60-day review process for products approved by either EMA or FDA. ● CTD procedure: 6-month review process for products not approved by EMA or FDA. (full review)