Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks
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, creatin...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-03-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2025.1544393/full |
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| author | Francisco D. Rodríguez-Gómez Francisco D. Rodríguez-Gómez Dominique Monferrer Dominique Monferrer Oriol Penon Pilar Rivera-Gil |
| author_facet | Francisco D. Rodríguez-Gómez Francisco D. Rodríguez-Gómez Dominique Monferrer Dominique Monferrer Oriol Penon Pilar Rivera-Gil |
| author_sort | Francisco D. Rodríguez-Gómez |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-63588cd0a6614209855e3e2ca63afb88 |
| institution | OA Journals |
| issn | 2296-858X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj-art-63588cd0a6614209855e3e2ca63afb882025-08-20T02:03:07ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-03-011210.3389/fmed.2025.15443931544393Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworksFrancisco D. Rodríguez-Gómez0Francisco D. Rodríguez-Gómez1Dominique Monferrer2Dominique Monferrer3Oriol Penon4Pilar Rivera-Gil5Asphalion SL, Barcelona, SpainIntegrative Biomedical Materials and Nanomedicine Lab, Department of Medicine and Life Sciences, Universitat Pompeu Fabra Barcelona Biomedicine Research Park (PRBB) Doctor Aiguader, Barcelona, SpainAsphalion SL, Barcelona, SpainOEM Technology Center, Werfen, Barcelona, SpainAsphalion SL, Barcelona, SpainIntegrative Biomedical Materials and Nanomedicine Lab, Department of Medicine and Life Sciences, Universitat Pompeu Fabra Barcelona Biomedicine Research Park (PRBB) Doctor Aiguader, Barcelona, SpainThe 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.https://www.frontiersin.org/articles/10.3389/fmed.2025.1544393/fullnanotechnology-enabled health productsregulatory pathwaysEuropean UnionUnited Stateshealthcare innovationmedical regulations |
| spellingShingle | Francisco D. Rodríguez-Gómez Francisco D. Rodríguez-Gómez Dominique Monferrer Dominique Monferrer Oriol Penon Pilar Rivera-Gil Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks Frontiers in Medicine nanotechnology-enabled health products regulatory pathways European Union United States healthcare innovation medical regulations |
| title | Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks |
| title_full | Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks |
| title_fullStr | Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks |
| title_full_unstemmed | Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks |
| title_short | Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks |
| title_sort | regulatory pathways and guidelines for nanotechnology enabled health products a comparative review of eu and us frameworks |
| topic | nanotechnology-enabled health products regulatory pathways European Union United States healthcare innovation medical regulations |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1544393/full |
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