Developement of ICSR E2B Guideline

Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (3): 144-146.

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Developement of ICSR E2B Guideline

HOU Yong-fang¹, DONG Duo¹, XIONG Wei-yi¹, LI Lan¹, LIU Hong-liang¹, LIU Rui², WAN Bang-xi²

1 Center for Drug Revaluation, CFDA, Beijing 100045, China;
2 Jiaxing Tai Mei Medical Technology Co., Ltd., Shanghai 200001, China

Received:2017-11-13 Revised:2018-05-04 Online:2018-03-20 Published:2018-05-04

Abstract

Abstract: ICH E2B has now become the standard of ICSR electronic transmission, and is widely used by ICH countries and non-ICH countries' authorities and enterprises. This paper introduces background and value of ICH E2B standard and the progress of E2B standard; discusses the practical significance of implementing E2B standard in the context of China as a member of ICH and the current situation of national adverse drug reaction monitoring system in China.

Key words: pharmacovigilance, E2B, ICH, ICSR

CLC Number:

R994.11

HOU Yong-fang, DONG Duo, XIONG Wei-yi, LI Lan, LIU Hong-liang, LIU Rui, WAN Bang-xi. Developement of ICSR E2B Guideline[J]. Chinese Journal of Pharmacovigilance, 2018, 15(3): 144-146.

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Developement of ICSR E2B Guideline

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