EMA launches adaptive licensing pilot project to improve access to medicines

The European Medicines Agency is inviting companies to participate in its adaptive licensing pilot project and has published a framework to guide discussions.

The adaptive licensing approach is 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.

Adaptive licensing requires the involvement of all stakeholders staggered approval or progressive licensing and is part of the EMA’s efforts to improve timely access for who have a role in determining patient access, including the EMA, the industry, health technology assessment (HTA) bodies, organizations issuing clinical treatment guidelines and patient organizations. All discussions will take place in a ‘safe harbor’ environment to allow free exploration of the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilization pathways in a confidential manner and without commitment from either side.