我们目前对纳米材料的了解主要建立在基础研究的数据上,并强调了纳米材料的应用和发展潜力。另一方面,标准评价方法,模型,曝光方法,标准,生物效应评价指南不充分。针对监管的瓶颈,中国的科研院所和监管机构密切合作,研究和建立了纳米医疗器械的评估体系,以含银纳米材料为例。在这样的背景下,参考材料,表征策略,建立了体内外分布和毒性评价标准。本文重点介绍了我国纳米医疗器械产品(以含银纳米医疗器械产品为例)的风险评估研究,包括表征和释放确定策略,组织中纳米银的测定,建立了三维皮肤模型和体外毒性评价标准。本文重点研究技术标准。因此,2021年发布了“纳米医疗器械安全性和有效性评估指南”,初步形成了纳米医疗器械市场进入框架,作为科学监管的重要组成部分。本指南监督纳米医疗设备的审查和监督,因此,为我国纳米医疗器械的市场准入提供了保障。本文分为:纳米医学的毒理学和监管问题>纳米材料的毒理学>纳米医学的毒理学和监管问题>纳米医学的监管和政策问题。
Our current knowledge on nanomaterials is mostly built on data from basic studies, and the application and developmental potentials of nanomaterials are emphasized. On the other hand, standard evaluation methods, models, exposure methods, standards, and guidelines for biological effect evaluation are inadequate. In response to the bottlenecks of supervision, scientific research institutes and regulatory organizations in
China have cooperated closely to research and establish an evaluation system for nanomedical devices, and silver-containing nanomaterials have been adopted as an example. In such a context, reference materials, characterization strategies, in vitro and in vivo distribution and toxicity evaluation standards have been established. This article highlights research on the risk assessment of nanomedical device products (taking silver-containing nanomedical device products as an example) in
China, including the characterization and release determination strategies, determination of
nanosilver in tissues, applications of three-dimensional skin models and in vitro and toxicity evaluation standards have been established. This article highlights research on technical standards. As a consequence, the \"Guidelines for the safety and effectiveness evaluation of nanomedical devices\" were published in 2021, and a market entry framework for nanomedical devices has been preliminarily formed as a significant component in scientific supervision. This Guideline supervises the review and supervision of nanomedical devices and, therefore, provides a guarantee for the market access of nanomedical devices in
China. This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine.