The EMA has established a framework for the regulation of nanomedicines to ensure their safety and efficacy. The agency assesses nanomedicines through a centralized procedure, which involves a comprehensive review by scientific committees such as the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Advanced Therapies (CAT). Key aspects evaluated include the physicochemical properties, pharmacokinetics, toxicology, and clinical data of the nanomedicines.
