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April 26, 2026Therapeutic Innovation & Regulatory Science0 citationsOpen Access

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

TWTakashi WakiSWShinya WatanabeTATakashi Ando

Key Points

  • The aim is to outline the present and future approaches to drug safety assessment in Japan using real world data.
  • Describes utilization of real world data from various sources for pharmacovigilance.
  • Covers the characteristics, advantages, and disadvantages of these data sources.
  • Discusses the Pharmaceuticals and Medical Devices Agency's perspective on drug safety.
  • Identifies how real world data contributes to post-marketing safety assessment.
  • Highlights current practices and proposes future enhancements in drug safety evaluation.
  • Indicates a direction toward integrating diverse data sources for better safety outcomes.

Abstract

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.

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Cite This Study

Waki et al. (2026) studied this question.

synapsesocial.com/papers/69edac074a46254e215b3cb7https://doi.org/10.1007/s43441-026-00964-6
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