The Status and Prospective of PSUR in China

Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (6): 333-335.

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The Status and Prospective of PSUR in China

YUAN Xing-dong¹ GAO Jing¹ ZHOU Juan¹ ZHONG Chang-ming¹ REN Jing-tian^2*

1 Jiangxi Adverse Drug Reaction Monitoring Center, Jiangxi Nanchang 330046, China;
2 Center for Drug Reevaluation, CFDA, Beijing 100045, China)

Received:2013-12-17 Revised:2016-02-03 Online:2014-06-08 Published:2016-03-02

Abstract

Abstract: Periodic safety update report(PSUR) is a kind of report that pharmaceutical manufacturers regularly compile security informations about a drug to the drug regulatorg departments.This paper explained the relative articles of PSUR based on the regulation. The status of the implement ation on PSUR was introduced, and the problems were analysized in our province. These data are used to infer the situation throughout the country. Related recommendations were proposed to promote the work on PSUR.

Key words: periodic safety update report(PSUR), status, prospective

YUAN Xing-dong GAO Jing ZHOU Juan ZHONG Chang-ming REN Jing-tian. The Status and Prospective of PSUR in China[J]. Chinese Journal of Pharmacovigilance, 2014, 11(6): 333-335.

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The Status and Prospective of PSUR in China

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