Charting the Managed Access Program Landscape
A Regulatory and Logistical Overview
Many patients with serious diseases cannot wait for an investigational product to move from the lab to the pharmacy shelf.
Even with recent tendencies towards accelerated marketing approval, new treatments do not make it to market fast enough. Moreover, while regulators and developers generally prefer that patients gain access to investigational drugs by participating in clinical trials, patients are not always eligible to take part.
Managed Access Programmes (MAPs), also known as compassionate use, expanded access, medical need or patient assistance programmes, are one solution for early access to investigational products that are gaining traction.
This approach differs significantly from the traditional drug development process and brings with it new regulatory and operational complexities. Without the right knowledge, resources, processes, and tools, clinical teams can be caught off guard by the demands of a MAP.
To learn more, read our whitepaper, which explains how MAPs differ amongst themselves, globally, and from randomised clinical trials; when they are appropriate; how they are regulated around the world; and how to plan for them.