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纳米技术健康产品的监管途径与指南：欧盟与美国框架的比较综述

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks.

作者信息

Rodríguez-Gómez Francisco D, Monferrer Dominique, Penon Oriol, Rivera-Gil Pilar

机构信息

Asphalion SL, Barcelona, Spain.

Integrative Biomedical Materials and Nanomedicine Lab, Department of Medicine and Life Sciences, Universitat Pompeu Fabra Barcelona Biomedicine Research Park (PRBB) Doctor Aiguader, Barcelona, Spain.

出版信息

Front Med (Lausanne). 2025 Mar 5;12:1544393. doi: 10.3389/fmed.2025.1544393. eCollection 2025.

DOI:10.3389/fmed.2025.1544393
PMID:40109724
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11919859/
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.

摘要

纳米技术与医疗保健的融合催生了纳米技术支持的健康产品（NHPs），有望在医学治疗和诊断方面带来革命性进展。尽管具有潜力，但这些产品的监管导航仍然复杂且往往滞后，为其临床应用造成了障碍。这篇综述文章重点剖析了NHPs的监管格局，特别是在欧盟和美国，以确定适用要求以及目前可用于满足监管期望的主要监管指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/f8e8681dba53/fmed-12-1544393-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/ee69a3098bf5/fmed-12-1544393-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/0e55fd30ff2f/fmed-12-1544393-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/3c23f9b8b769/fmed-12-1544393-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/2ed74bca2768/fmed-12-1544393-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/39a389cc3fc9/fmed-12-1544393-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/f8e8681dba53/fmed-12-1544393-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/ee69a3098bf5/fmed-12-1544393-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/0e55fd30ff2f/fmed-12-1544393-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/3c23f9b8b769/fmed-12-1544393-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/2ed74bca2768/fmed-12-1544393-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/39a389cc3fc9/fmed-12-1544393-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dba0/11919859/f8e8681dba53/fmed-12-1544393-g006.jpg

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[6]
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[7]
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本文引用的文献

[1]
Twenty years of nanotoxicology: how AI could make the difference.

Front Toxicol. 2024-9-18

[2]
Real Time and Spatiotemporal Quantification of pH and HO Imbalances with a Multiplex Surface-Enhanced Raman Spectroscopy Nanosensor.

ACS Mater Au. 2023-2-15

[3]
Evolution of nanomedicine formulations for targeted delivery and controlled release.

Adv Drug Deliv Rev. 2023-9

[4]
Enabling technologies driving drug research and development.

Front Med (Lausanne). 2023-3-9

[5]
Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products.

Front Public Health. 2023

[6]
Nanotechnology: A Revolution in Modern Industry.

Molecules. 2023-1-9

[7]
Where Is Nano Today and Where Is It Headed? A Review of Nanomedicine and the Dilemma of Nanotoxicology.

ACS Nano. 2022-7-26

[8]
Nanoparticle classification, physicochemical properties, characterization, and applications: a comprehensive review for biologists.

J Nanobiotechnology. 2022-6-7

[9]
Controlled nano-agglomerates as stabile SERS reporters for unequivocal labelling.

Sci Rep. 2022-5-28

[10]
The Promise of Nanotechnology in Personalized Medicine.

J Pers Med. 2022-4-22

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