源自日本学术研究的新型医疗产品类别分类对其产业化的意义

T. Morino, N. Kawai, T. Yasui
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引用次数: 0

摘要

这次给主编的通信讨论了源自日本学术研究的医疗产品的类别分类过程,并以作者的产品为例进行了展示。2017年美国指南,“产品分类为药品和器械及附加产品”。分类问题:行业和FDA工作人员指南。参考了《最终指南》,并介绍了器械定义的关键条款。在美国,当产品的主要预期目的没有通过化学作用实现时,医疗产品被定义为器械。FDA对两种发热纳米颗粒的设备定义的例子如下:指南中所示的金纳米颗粒和源自日本学术研究的磁铁矿阳离子脂质体复合颗粒(以前称为磁铁矿阳离子脂质体)。关于日本的分类过程,提出了学术界和行政机构之间进行详细讨论的必要性,以促进其技术向日本工业界的转移。
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Significance of Category Classification of Novel Medical Products Originated from Japanese Academic Researches with Regards to Its Industrialization
This communication to chief editor discussed category classification process of medical products originated from Japanese academic researches, showing that of authorsʼ product for example. US guideline in 2017, “Classification of Products as Drugs and Devices & Additional Products. Classification Issues: Guidance for Industry and FDA Staff. Final Guidance”, was refereed and key provisions for device definition were introduced. In US, medical products were defined as device when primary intended purpose of the product was not achieved through chemical action. Examples of FDAʼs device definition of two kinds of heat generating nanoparticles were shown as gold nanoparticles illustrated in the guideline and magnetite cationic lipid composite particles (formerly named magnetite cationic liposomes) originated from Japanese academic research. Concerning category classification process in Japan, necessity of detailed discussion between academia and administrative agency was issued in order to facilitate its technology transfer to Japanese industry.
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