Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (1): 28-31.

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Surveillance for Therapeutic Inequivalence in Taiwan Area of China

CHEN Zhi-dong   

  1. Sixth People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China
  • Received:2015-10-30 Revised:2016-02-25 Online:2016-01-08 Published:2016-02-25

Abstract: Objective To share the experiences of surveillance for therapeutic inequivalence (TIE) in Taiwan area of China. Methods Based on the related data, TIE related issues such as definition, procedures for report and assessment, suspected reported cases, and active surveillance mechanism in Taiwan area of China were all introduced. Results There were 488 TIE reported cases from 2009 to 2014 in Taiwan area of China, only one case was found related to the drug of levothyroxine tablet after assessing all the TIE reported cases. Conclusion Now TIE surveillance is an important part of drug safety surveillance, which plays more and more roles in ensuring the safety of drug use as well as improving the quality of drug in Taiwan area of China.

Key words: therapeutic inequivalence, surveillance, Taiwan area of China

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