Snapshot

The Reliance Pathway pathway has been developed by the Kuwait Food and Drug Authority (KuFDA) of Kuwait.

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 Japan United States

The review process begins with the local agent (or sponsor) sending the registration dossier together with a covering letter to the Kuwait Drug and Food Control Manager (KDFC) formally demanding the pharmaceutical material registration. Manufacturers submit their drug application to Kuwaiti MoH for market authorization; approvals take 30-60 days.