Thoughts on Implementing E2B(R3) in Individual Case Safety Reports in China

doi:10.19803/j.1672-8629.2019.10.03

Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (10): 588-590.
DOI: 10.19803/j.1672-8629.2019.10.03

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Thoughts on Implementing E2B(R3) in Individual Case Safety Reports in China

HOU Yongfang¹, FANG Kairui¹, QI Yan¹, WANG Qing², LIU Hongliang¹

1 Center for Drug Reevaluation, NMPA,Beijing 100022, China;
2 School of Information Science and Technology of Tsinghua University,Beijing 100084, China

Received:2019-10-24 Revised:2019-10-24 Online:2019-10-20 Published:2019-10-24

Abstract

Abstract: Objective To offer thoughts on implementation of E2B(R3) in individual case safety reports (ICSR)in China. Methods By interpreting the significance and ways of implementating E2B (R3), the challenges to and countermeasures for the implementation of E2B (R3) were explored. Results & Conclusion The implementation of E2B (R3) is conducive to the sharing and exchange of ICSR. There are many formidable challenges. E2B (R3) needs to be gradually implemented based on the level of development of adverse drug reaction monitoring.

Key words: E2B(R3), ICSR, implementation

CLC Number:

R951

HOU Yongfang, FANG Kairui, QI Yan, WANG Qing, LIU Hongliang. Thoughts on Implementing E2B(R3) in Individual Case Safety Reports in China[J]. Chinese Journal of Pharmacovigilance, 2019, 16(10): 588-590.

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Thoughts on Implementing E2B(R3) in Individual Case Safety Reports in China

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