Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (3): 149-151.

• Orginal Article • Previous Articles     Next Articles

An Introduction to and Application of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E2B

YE Xiao-fei1, Guo Xiao-jing1, ZHAO Lu1, 2, HE Jia1   

  1. 1 Department of Health Statistics, Second Military Medical University, Shanghai 200433, China;
    2 Brigade of Graduate Student Management, Second Military Medical University, Shanghai 200433, China
  • Received:2011-06-09 Online:2012-03-10 Published:2015-08-10

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Abstract: More and more attention has been paid to the adverse drug reaction surveillance. Spontaneous reporting system has been developed in China and the authority has made great effort to improve the quality of surveillance. In this article, we presented a brief introduction to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, E2B. We expect that the adverse drug reaction surveillance in China will benefit a lot from this guideline.

Key words: adverse drug reaction, ICH