Management of individual adverse drug reaction reports

doi:10.19803/j.1672-8629.20230264

Abstract

Abstract: Objective To summarize and analyze the key points of ways in which individual case safety reports (ICSRs) are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders (MAHs) in handling ICSRs. Methods Based on a review of related literature and regulations at home and abroad, the whole process of ICSR management was introduced. Speaking from experience, we discussed the problems that were worthy of attention in the course of ICSR management. Results and Conclusion ICSRs underline pharmacovigilance by MAHs, who should collect, process, and submit ICSRs in accordance with related laws and regulations.

Key words: pharmacovigilance, MAHs, adverse drug reactions, individual case safety reports(ICSRs), safety, Good Pharmacovigilance Practice

CLC Number:

R954

LI Xiaozhu, WANG Qiang, PANG Yu, ZHANG Yijing. Management of individual adverse drug reaction reports[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 975-977.

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