Adaptive Licensing: Industry On Board, With Caveats

Adaptive licensing is widely seen as the next major step in refining the drug development process and better meeting patients' needs. Hans-Georg Eichler, MD, senior medical officer at the EMA and a key driver of its pilot project, says adaptive licensing (AL) represents a shift from the "magic moment" of approval, when an unlicensed product suddenly becomes a licensed one and the treatment population grows rapidly, to a system of "life-span management" where the treated population grows more slowly and the capture of patient experience contributes to real-world information.

The component parts of adaptive licensing – conditional and exceptional marketing authorizations, compassionate-use programs, risk management plans, patient registries, and...