Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (3): 140-143.

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Introduction to Causality Assessment Method of Cosmetic Adverse Reactions in European Union

SHEN Lu1, LU Chang-fei2, LIU Wei1, ZHANG Hua1, GUO Xue1, PENG Li-li1, LI Xin-ling1   

  1. 1Centre for Drug Reevaluation, CFDA, Beijing 100045, China;
    2Shandong Centre for ADR Monitoring, Shandong Jinan 250013, China
  • Received:2014-01-07 Revised:2016-02-03 Online:2014-03-08 Published:2016-02-03

Abstract: This article introduced the formulation principles, standards and operation of the causality assessment method of cosmetic adverse reactions in EU. This method has strict and rigorous formulation principles and easily understood evaluation logic. The adopted decision tree mode is the most critical. This method is meaningful for cosmetic adverse reactions monitoring work in China.

Key words: cosmetic adverse reactions, causality assessment, method

CLC Number: