Role of Pharmaceutical Enterprise in Periodic Safety Update Report

Abstract

Abstract: The periodic safety update report (PSUR) as an important tool for pharmacovigilance is to improve our adverse drug reaction reporting system, meanwhile it is an important method for drug safety administration of post-marketing drugs. PSUR should be submitted by pharmaceutical enterprises at defined time point. This paper analyzed and evaluated the present situation of PSUR in our country together with responsibility and challenge of pharmaceutical enterprises to bring up corresponding suggestion．

Key words: periodic safety update report, pharmacovigilance, pharmaceutical enterprise, suggestion

CLC Number:

WEI Shu-min, ZHEN Zhi-qin, LI Ke-nan. Role of Pharmaceutical Enterprise in Periodic Safety Update Report[J]. Chinese Journal of Pharmacovigilance, 2014, 11(9): 547-549.

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Role of Pharmaceutical Enterprise in Periodic Safety Update Report

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