J Pharmacoepidemiol Risk Manage.  2022 Mar;14(1):11-18. 10.56142/2022.14.1.11.

Comparison of Expedited Reporting System for Investigational Drugs in the U .S., EU and South Korea

• Cha JW
• Rhee HE
• Park SJ
• Kim S
• Cho HK
• Lee JE
• Lee B
• Shim DY
• Shin JY

• KMID: 2534669
• DOI: http://doi.org/10.56142/2022.14.1.11

Abstract

As the number of clinical trials conducted worldwide continues to increase, the management of safety information of investigational medicinal products used during clinical trials has become ever more important. Individual expedited reporting is needed when uspected Unexpected Serious Adverse Reactions (SUSARs) occur. Investigational New Drug (IND) application sponsors are required to submit an expedited IND safety report for serious cases. The United States, Europe, and South Korea have established expedited reporting systems that reflect the ‘E2A, Clinical safety data management: definitions and standards for expedited reporting’ developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The Korean guidelines on the safety for investigational medicinal products have gained national recognition, and recent revisions specified categories and strengthened the standards for expedited reporting. This paper addresses the details of domestic and international expedited reporting systems and analyzes the similarities and differences between the two.

Keyword

Safety management; Investigational New Drug (IND); Suspected unexpected serious adverse reaction (SUSAR); Expedited reporting