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<p>For pharmacovigilance, the Pharmaceuticals and Medical Devices Agency in Japan has utilized real world data (RWD) from multiple sources, including individual case safety reports, and medical information databases that capture routinely collected data from clinical practice. These RWD have their own characteristics with advantages and disadvantages. In this commentary, we describe current and future direction of post-marketing drug safety assessment in Japan.</p>

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Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月24日

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  • Takashi Waki,
  • Shinya Watanabe,
  • Takashi Ando,
  • Kazuhiro Kajiyama,
  • Koichi Fukuda,
  • Eiko Iwasa,
  • Yukari Iwasaki,
  • Masao Iwagami,
  • Taihei Tanaka,
  • Daisuke Maeda,
  • Yoshiaki Uyama

摘要

For pharmacovigilance, the Pharmaceuticals and Medical Devices Agency in Japan has utilized real world data (RWD) from multiple sources, including individual case safety reports, and medical information databases that capture routinely collected data from clinical practice. These RWD have their own characteristics with advantages and disadvantages. In this commentary, we describe current and future direction of post-marketing drug safety assessment in Japan.