[Case study of Chinese medicine after listing of pharmacovigilance]

Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2836-9.
[Article in Chinese]

Abstract

With the continuous increasement of adverse Chinese drug reaction reporting, especially Chinese traditional medicine injection, it becomes the key part of the post-marketing evaluation. The issue based on this research background becomes the hot research direction. But the truth is that the history of Chinese medicine and western medicine is different and the theory is not a system either, here different means between pharmacovigilance of Chinese medicine and western medicine, there are still many gaps. This becomes a barrier for Chinese medicine entering the international market. This article summarizes try to order the SFDA's adverse reaction reporting database of traditional Chinese medicine, and using three kinds of data mining methods used by WHO, the U. S. Food and Drug Administration, to establish suitable system for Chinese market after the evaluation of pharmacovigilance.

Publication types

  • English Abstract
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Child
  • Child, Preschool
  • Data Mining
  • Female
  • Humans
  • Male
  • Medicine, Chinese Traditional / adverse effects*
  • Middle Aged
  • Pharmacovigilance*