Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (9): 533-535.

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Inspiration from EudraVigilance Access Policy for Medicines for Human Use

LIU Wei ,DU Xiao-xi* ,SHEN Lu   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2013-07-29 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

Abstract: This article reviews EudraVigilance Access Policy for Medicines for Human Use. The stakeholder groups granted access to EudraVigilance data can be summarized as follows: medicines regulatory authorities, the european Commission and the Agency, healthcare professionals and the general public, marketing authorisation holders and sponsors of clinical trials and research organizations. They have been granted different access authorization. The article analyses inspiration from EudraVigilance Access Policy.

Key words: EudraVigilance, access right

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