Analysis of safety reporting requirements during medical device clinical trials in Japan

Kentaro Azuma*, Hiroshi Iseki

*この研究の対応する著者

研究成果: Article査読

3 被引用数 (Scopus)

抄録

Regulatory convergence in safety reporting requirements for medical device clinical trials has not yet been achieved. The Global Harmonization Task Force (GHTF) issued new guidance, GHTF/SG5/N5, on this topic in August 2012. First, we compared current reporting requirements for drug and medical devices in Japan with the international guidelines International Conference on Harmonization (ICH)-E2A/E2F and GHTF/SG5/N5. As a result, we confirmed that Japan's expedited reporting requirements are nearly the same for drugs and medical devices and that these requirements are similar to those described in ICH-E2A. We also found that GHTF/SG5/N5 differs from the ICH-E2A in several ways. We sorted these differences into three categories: reportable events, reporting time frame, and definitions of terms. Although there are several equivalent terms between the ICH and GHTF guidelines, the terms Serious Health Threat and Device Deficiency are only defined in GHTF/SG5/N5. The reporting time frame for a Serious Adverse Event is either 10 or 30 days for medical devices; expedited reporting is not required according to ICH-E2A, but it is covered in the annual Development Safety Update Report in ICH-E2F. GHTF/SG5/N5 recommends substantially stricter requirements than the current requirements in Japan. Therefore, the Ministry of Health, Labour and Welfare (MHLW) seemed to have prioritized the introduction of consistent definitions of terms while maintaining the current reporting time frame, rather than introducing GHTF guidance as it is. This policy is in accordance with the draft proposal on the revision of safety reporting requirements issued by MHLW in October 2012.

本文言語English
ページ(範囲)234-241
ページ数8
ジャーナルJournal of Artificial Organs
16
2
DOI
出版ステータスPublished - 2013 6月
外部発表はい

ASJC Scopus subject areas

  • 医学(その他)
  • 生体材料
  • 生体医工学
  • 循環器および心血管医学

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