What is a regulatory pathway and why do they matter?

A regulatory pathway is a mechanism which allows a product to be imported into a country when otherwise it would be unavailable.

That could be because it hasn’t been approved yet, has been withdrawn from market, is in shortage or if your patient is unable to participate in a clinical trial.

They exist to ensure product quality, safety and efficacy. In most countries there are multiple pathways, the challenge is to identify the most appropriate pathway for the benefit of your individual patient – considering quality, speed and funding.

If there are no official guidelines in your country or you just don’t know, we can point you in the right direction. Our 30 years’ experience tells us there is always a way, you just need to know where to look.

Explore our popular questions about unlicensed medicines