Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (8): 478-481.

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Overview of Pharmacovigilance Inspection in UK

DONG Duo, WU Gui-zhi, WANG Dan, FENG Hong-yun, WANG Ya-li, CHENG Gang   

  1. Center For Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2016-02-03 Revised:2016-02-03 Online:2014-08-08 Published:2016-03-02

Abstract: To promote pharmaceutical manufacturer, the first person for products safety to undertake post-marketing surveillance responsibility,UK initiated pharmacovigilance inspection programme in 2003, and now it formed a set of complete inspection system.This article introduced pharmacovigilance inspection type, process, findings and so on in UK, and proposed recommendation on adverse drug reaction report and monitoring inspection responsiblity division, guideline, self-checking indicatior system and information communication.

Key words: UK, pharmacovigilance, adverse drug reaction, inspection

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