Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (7): 419-423.

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Analysis and Reflection on the Current Situation of International Public Reporting of Adverse Drug Reactions

CHANG Hong1, TIAN Yue-jie2, LIU Hong-liang3, WU Shi-fu2,*, WANG Ling3, LI Yu-ji2, WANG Xiao-jun2, WANG Bing-jie4, ZHAO Ru-min5, ZHAO Hui-rong6, ZHANG Yun-duan7   

  1. 1 Jining Institute for Food and Drug Control, Shandong Jining 272100, China;
    2 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
    3 Center for Drug Reevaluation, CFDA, Beijing 100045,China;
    4 Zibo Center for ADR Monitoring, Shandong Zibo 255000,China;
    5 Binzhou Center for ADR Monitoring, Shandong Binzhou 256600, China;
    6 Traditional Chinese Medicine Hospital of Penglai, Shandong Penglai 265600, China;
    7 People's Hospital of Huangdao District, Shandong Qingdao 266400, China
  • Received:2017-06-06 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

Abstract: A relatively perfect adverse drug reactions monitoring system has been established in China. The public was encouraged to report adverse drug reactions in our country while the number of the public reports was very small over the years. To provide reference for the establishment of public reporting model of adverse drug reactions in China, current situations of the public reporting of adverse drug reactions in the developed countries mainly including the United States, Canada, Australia and the UK was analyzed, and the laws and regulations, the reporting ways and the reporting forms were summarized.

Key words: international, adverse drug reactions monitoring, spontaneous reporting, public reporting

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