An Overview of EudraVigilance and Implications for China

doi:10.19803/j.1672-8629.2021.11.13

Abstract

Abstract: Objectiv eTo offer some tips about upgrading adverse drug reaction monitoring systems in China by analyzing the EU's drug safety monitoring system (EudraVigilance). Methods EudraVigilance was studied from three perspectives: case reporting, data management, and data analysis. The key functions and methods of implementation of EudraVigilance were analyzed. Results EudraVigilance collected individual case safety reports(ICSR) through gateway reporting and web reporting. Methods of data quality control in EudraVigilance included MedDRA, drugs dictionaries, case recoding and monitoring of duplicates. Conclusion It is recommended that the Chinese counterpart learn from EudraVigilance to improve adverse drug reaction monitoring systems in China by establishing gateway reporting, web reporting and other reporting channels, improving data quality using terminology dictionaries and duplicate monitoring, and establishing a data warehouse to support risk signal identification.

Key words: drug safety, EudraVigilance, monitoring, gateway, duplicates

CLC Number:

R994.11

HOU Yongfang, LIU hongliang, QI Yan. An Overview of EudraVigilance and Implications for China[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1058-1061.

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