Adaptive licensing

A prospectively planned process, starting with the early authorization of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorization to expand access to the medicine to broader patient populations.
As a holistic approach, adaptive licensing requires the involvement of all stakeholders who have a role in determining patient access, including the European Medicines Agency, the industry, health technology assessment (HTA) bodies, organisations issuing clinical treatment guidelines and patient organisations
Synonym: progressive licensing, staggered approval