纳米技术健康产品的分类系统具有科学和监管应用
Francisco D Rodríguez-Gómez1,2, Oriol Penon1, Dominique Monferrer1
1Asphalion SL, Barcelona, Spain.
Frontiers in medicine
|August 21, 2023
概括
建议对纳米技术支持的健康产品 (NHPs) 进行新的分类系统,以解决缺乏监管指导方针的问题. 该系统有助于监管机构和制造商在开发和评估创新的NHP时进行导航.
科学领域:
- 纳米技术纳米技术
- 监管科学 监管科学
- 健康产品开发 医疗产品开发
背景情况:
- 纳米技术支持的健康产品 (NHPs) 面临监管障碍,因为缺乏具体指导方针.
- 协调的定义和分类系统对于NHP的标准化监管评估至关重要.
研究的目的:
- 提出一个新的NHP分类系统.
- 为分类纳米基础创新和监管指南提供一个工具.
- 支持监管战略的制定和制造商的合规性.
主要方法:
- 开发了一个结合科学和监管原则的分类系统.
- 标准包括:主要作用方式,化学成分,医疗用途和纳米制造方法.
主要成果:
- 已经建立了一个新的,多标准的NHP分类系统.
- 该系统允许根据NHP类型对创新和指南进行分类.
结论:
- 拟议的分类系统是评估NHP技术状态的工具.
- 它帮助监管机构制定指导方针,帮助制造商协调发展计划.
- 方便患者获得创新的纳米技术支持的健康产品.
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