Konishi Akihide, Isobe Soichiro, Sato Daisaku
Office of Medical Device III, Pharmaceuticals and Medical Devices Agency, 3-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
Compliance and Narcotics Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan.
J Vasc Interv Radiol. 2018 May;29(5):657-660. doi: 10.1016/j.jvir.2017.12.022. Epub 2018 Mar 13.
In Japan, a recent issue that required an urgent response was the streamlining of regulations concerning clinical trials of medical devices. On July 31, 2017, the Ministry of Health, Labour and Welfare enacted a new regulatory framework called the fast-break scheme for innovative medical devices aiming to expedite patient access while reducing the premarket regulatory burden of clinical trials and enhancing postmarketing commitments. The new framework is expected to provide greater benefits to patients who require access to new medical devices and to companies via improved transparency and predictability, as well as to reduce the social and medical cost incurred for medical innovation.
在日本，近期需要紧急应对的一个问题是简化有关医疗器械临床试验的法规。2017年7月31日，厚生劳动省颁布了一项名为创新医疗器械快速审批计划的新监管框架，旨在加快患者获得医疗器械的速度，同时减轻临床试验的上市前监管负担，并加强上市后承诺。新框架预计将通过提高透明度和可预测性，为需要使用新医疗器械的患者和公司带来更大益处，同时降低医疗创新产生的社会和医疗成本。
