ADAPT SMART welcomes EMA report on adaptive pathways pilot

摘要

ADAPT SMART (adaptsmart.eu) welcomes EMA's report on its adaptive pathways pilot, considering this as a positive step in the current multi-stakeholder discussions about early access to medicines via a Medicines Adaptive Pathways to Patients (MAPPs) in the EU. MAPPs aims to foster access to beneficial treatments for specific, well-defined, patient groups at the earliest appropriate time in the product lifespan in a sustainable and affordable fashion. It's not a new route of approval for medicines, but makes use of existing approval tools, such as conditional approval, to address areas of high unmet need.