Chinese Journal of Pharmacovigilance ›› 2010, Vol. 7 ›› Issue (2): 81-85.

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Use of WHOART and MedDRA in Adverse Reaction Monitoring

WU Gui-zhi, TIAN Chun-hua, WANG Dan, FENG Hong-yun, CHEN Yi-xin   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2016-02-19 Revised:2016-02-19 Online:2010-02-08 Published:2016-02-19

Abstract: World Health Organization Adverse Reaction Terminology(WHOART) and Medical Dictionary for Regu-latory Activities(MedDRA) developed by International Conference on Harmonisation are most often used terminology to classify and code adverse reaction terms in post-marketing safety surveillance and drug adverse reaction monitoring. This article introduced term definitions, rules and conventions, hierarchy structure, characteristics, the applications in coding and data analysis of WHOART and MedDRA. On the basis of analyzing the strongpoint and shortcoming of WHOART and MedDRA terminology now in use, the current status of WHOART and potential use of MedDRA in China are discussed.

Key words: WHOART, MedDRA, adverse reaction monitoring, use

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