Chinese Journal of Pharmacovigilance ›› 2020, Vol. 17 ›› Issue (1): 26-30.
DOI: 10.19803/j.1672-8629.2020.01.06

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Brief Analysis of 2018 Annual Report of EudraVigilance

DONG Duo, LIU Wei, FAN Yan, PENG Lili, WANG Tao, WANG Dan   

  1. Center For Drug Reevaluation, NMPA, Beijing 100022, China
  • Received:2019-05-16 Revised:2020-01-15 Online:2020-01-15 Published:2020-01-15

Abstract: Objective To analyze the 2018 Annual Report on EudraVigilance so as to provide reference for improving ADR monitoring in China. Methods By literature review, the progress and advantages of the EU pharmacovigilance system in 2018 were analyzed before recommendations were made for ADR monitoring in China. Results EudraVigilance is the central pillar of safety surveillance of European medicines. It has delivered enhanced functionalities that can ensure better support to pharmacovigilance activities and the protection of public health. Conclusion Based on the experience of the EU, it is suggested that we continue to optimize the adverse drug reaction database, explore and research the transparency of surveillance data, and enrich the contents of the annual report in China.

Key words: EU, EudraVigilance, annual report

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