Comparative Analysis of Real-World Data Utilization in Regulatory Decision-Making: Current Status in South Korea compared to FDA and EMA

• 발행기관: 대한약학회
• 저자명: Minsung Kim Hyun Jin Han Miryoung Kim Jiyeon Lee Yoonjin Lee Hae Sun Suh
• 간행물 정보: 『약학회지』제69권 제4호(2025년), 353~363쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.08.31

국문 초록

Randomized Controlled Trials are the gold standard for clinical evidence but have limitations in reflecting realworld settings. To address this, regulatory agencies are increasingly utilizing Real-World Data (RWD) and Real-World Evidence (RWE). This study compared the purpose of RWD/RWE utilization in regulatory decision-making based on drugs approved by the FDA/EMA and their corresponding approval reports from MFDS to assess the current status of RWD/ RWE utilization in South Korea over the past five years. Approval reports were reviewed using predefined RWD/RWErelated keywords. A review of FDA/EMA and MFDS approval reports revealed that while FDA and EMA predominantly utilized RWD/RWE for post-marketing evaluations (55%), the MFDS applied RWD/RWE less frequently and without a strong concentration in specific regulatory contexts. However, in South Korea drug approval reports from 2019-2024, of 242 distinct approvals, only 22 cases used RWD/RWE. Additionally, only 1 case (4.5%) showed a significant influence of RWD/RWE indicated by its explicit mention in the reviewer’s evaluation. This suggests that the use of RWD/RWE differed significantly between the FDA/EMA and MFDS, even for the same drug. Moreover, the use of RWD/RWE in South Korea was relatively limited, highlighting that the need for further research to explore the underlying reasons.

목차

Introduction

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Acknowledgment

Conflicts of Interest

References

키워드

Real-world data Real-world evidence Regulatory decision Efficacy evaluation