Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks
Francisco D. Rodríguez-Gómez, Dominique Monferrer, Oriol Penon, Pilar Rivera Gil
Abstract
The integration of nanotechnology into healthcare has introduced Nanotechnology-Enabled Health Products (NHPs), promising revolutionary advancements in medical treatments and diagnostics. Despite their potential, the regulatory navigation for these products remains complex and often lagging, creating barriers to their clinical application. This review article focuses on dissecting the regulatory landscape for NHPs, particularly in the European Union and the United States, to identify applicable requirements and the main regulatory guidelines currently available for meeting regulatory expectations.
Topics & Concepts
LaggingEuropean unionNanotechnologyRegulatory scienceHealth careHealthcare systemRisk analysis (engineering)BusinessManagement sciencePolitical scienceEngineeringMedicineInternational tradeLawMaterials sciencePathologyNanoparticles: synthesis and applicationsNanotechnology research and applicationsBiomedical Ethics and Regulation