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

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.