Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (10): 591-593.
DOI: 10.19803/j.1672-8629.2019.10.04

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Impact of E2B(R3) Implementation on Information System Construction in Drug Safety Related Institutions in China

WANG Qing, REN Wei, YANG Jijiang   

  1. Research Institute of Information Technology, Tsinghua University, Beijing 100084, China
  • Received:2019-10-24 Revised:2019-10-24 Online:2019-10-20 Published:2019-10-24

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Abstract: Objective To explore the impact of implementing E2B (R3) in the field of pharmaceutical supervision on the development of information systems for pharmacovigilance and ADR monitoring by related institutions in the future. Methods The process and scope of E2B (R3) implementation were analyzed, and the possible impact of E2B (R3) implementation on China's regulatory bodies, medical institutions and related enterprises in the construction of their respective information systems was explored. Results & Conclusion The implementation of E2B (R3) is an important measure in the field of pharmaceutical supervision in China. It has posed a series of challenges to the information system construction of regulatory agencies, medical institutions and related enterprises. Those institutions need to take corresponding measures related to overall planning, system construction and standard compatibility.

Key words: E2B(R3), ICSR, pharmacovigilance, information system

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