One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M&V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.

• 이경진(식품의약품안전청)
• 박경식(식품의약품안전청)
• 김정훈(식품의약품안전평가원)
• 이영주(식품의약품안전평가원)
• 윤태형(식품의약품안전평가원)
• 노기미(식품의약품안전평가원)
• 박미선(식품의약품안전평가원)
• 임동길(식품의약품안전평가원)
• 윤창용(식품의약품안전평가원)
• 정자영(식품의약품안전평가원)