Chinese Journal of Pharmacovigilance ›› 2011, Vol. 8 ›› Issue (10): 596-599.

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Analysis on Collecting Information for Adverse Drug Reaction and Ways to Report Through Spontaneous Reporting System in China

WU Gui-zhi, WANG Chun-ting, ZHANG Li   

  1. Center for Drug Reevaluation, SFDA Beijing 100045, China
  • Received:2011-04-20 Online:2011-10-10 Published:2015-07-30

Abstract: Collecting information for adverse drug reactions and ways to collect are two determined factors to fast and effectively collect adverse drug reactions through the spontaneous reporting system. This information usually is represented in a drug adverse reaction reporting form and its instructions. The instructions usually include principle for reporting, what to report, how to report and confidentiality. This article compared the drug adverse reaction reporting form and instructions from United Kingdom, United States, Australia and Canada with the reporting from our country. Some suggestions on how to optimize the collecting information for adverse drug reaction and ways to report in our country were also discussed.

Key words: adverse reaction information, drug adverse reaction reporting form, compare analysis

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