The device lag and associated factors for innovative medical devices in Japan compared to the United States

2022 Fiscal Year Final Research Report

• Project/Area Number: 19K10514
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 58010:Medical management and medical sociology-related
• Research Institution: Nagoya City University
• Principal Investigator: Fukuta Hidekatsu 名古屋市立大学, 医薬学総合研究院(医学), 准教授 (80448711)
• Project Period (FY): 2019-04-01 – 2023-03-31
• Keywords: デバイスラグ / 薬事承認

Outline of Final Research Achievements

The medical devices approved in Japan between April 2001 and March 2020 were included in this study. Changes in submission lag (difference between submission date in Japan and submission date in US), review lag (difference between review time in Japan and review time in US), and device lag (sum of submission lag and review lag) were evaluated. Device lag and review lag were shorter for late-stage approved devices (domestic approval after March 2013) compared to early-stage approved devices (domestic approval before March 2013). The domestic review time for prioritized review devices was shorter than that for non-prioritized review devices. The positive determinant of submission lag was 510K devices, and the negative determinant was global clinical trials. A positive determinant of examination lag was 510K devices.

Free Research Field

レギュラトリーサイエンス

Academic Significance and Societal Importance of the Research Achievements

日本では医療機器の薬事承認が欧米よりも遅れることが多い。この現象はデバイスラグと呼ばれている。本研究により、デバイスラグは改善傾向にはあるが解消には至っていないことが明らかとなった。さらに、国際共同治験により申請ラグは短縮され、優先審査品目の国内審査時間も短縮されていたが、510K品目に代表される比較的リスクの低い医療機器が申請ラグおよび審査ラグの要因であることが示された。デバイスラグの解消に向けて、国際共同治験の促進および低リスク品目の国内早期申請の促進と審査迅速化対策が急務と考えられた。