Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (10): 611-613.

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Introduction of Management and Reporting of Adverse Reactions to Medicinal Products in European Union

DONG Duo, LIU Wei, YANG Le, LIU Cui-li, CHENG Gang   

  1. Center For Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2014-08-02 Revised:2016-02-03 Online:2014-10-08 Published:2016-03-02

Abstract: By introducing good pharmacovigilance prctice on management and reporting of adverse reactions to medicinal products in EU, it was more cleared to know the definition of adverse reactions and working process in EU, such ascollection of reports, validation of reports, follow-up of reports, data management, quality management.It provided the example and refrence for perfecting and developing drug adverse reaction reporting and monitoring system in China.

Key words: European Union, pharmacovigilance, adverse reactions, management, reporting

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