Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (7): 411-413.

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Upgrade of EudraVigilance in the EU and Its Considerations

WANG Tao, WANG Dan, FAN Yan, DONG Duo*   

  1. Center For Drug Reevaluation, CFDA, Beijing 100022, China
  • Received:2018-08-08 Revised:2018-08-08 Online:2018-07-20 Published:2018-08-08

Abstract: Objective To introduce the main and upgraded features of EudraVigilance, so as to provide consideration and reference for the development of our national ADR monitoring in China. Methods Based on 2017 Annual Report on EudraVigilance for the European Parliament, the council and the commission, the new and enhanced functionalities of this database were analyzed. Results The enhanced functionalities of this database were mainly focused on functionalities subject to audit, the dictionary for medicinal product information and medical literature monitoring, etc. Conclusion The adverse reaction monitoring system in China still needs to be strengthened in internationalization of data formats, expansion of data sharing and improvement of drug information database.

Key words: medicines for human use, database, function, pharmacovigilance

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