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Open access
Nov 2026
Regulatory Pathways and Pivotal Trial Characteristics of Medicines Designated under the European Medicines Agency's Priority Medicines Scheme Approved between 2018 and 2024.
BACKGROUND AND OBJECTIVE The European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme supports the development of medicines addressing unmet medical needs through early scientific and regulatory guidance. The aim of this study was to describe the regulatory pathways and pivotal trial characteristics of PRIME-d...
Vanessa A. Prieto, María Luján Iavecchia, Esther Cucurull et al.
· Pharmaceutical Medicine · 0 citations