The Current State of Regulatory Post-Marketing Studies in Japan: A Questionnaire Survey on Good Post-Marketing Study Practice

Key Points

• To explore recent trends in post-marketing studies (PMSs) under Good Post-Marketing Study Practice (GPSP) in Japan.
• Conducted a questionnaire survey on PMSs in Japan.
• Analyzed responses based on recent regulatory changes, including revisions to Decision-Tree Notification.
• Considered the Q&A on All-case Surveys issued on July 18, 2024.
• Identified key trends in PMS practices influenced by GPSP guidelines.
• Revealed the impact of recent regulatory changes on the conduct of PMSs.