Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (5): 406-410.
DOI: 10.19803/j.1672-8629.2021.05.02

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Comparison of International Pharmacovigilance of Traditional Chinese Medicine and Natural Medicines

WU Hao1,2, ZHANG Bing1,2,*, LIN Zhijian1,2, ZHANG Xiaomeng1,2   

  1. 1School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China
  • Received:2020-02-26 Online:2021-05-15 Published:2021-05-12

Abstract: Objective To provide reference for the construction of pharmacovigilance systems of traditional Chinese medicine(TCM) and natural medicines by analyzing the development of pharmacovigilance of TCM and natural medicines. Methods Domestic and foreign literature was searched. Laws, regulations and guidelines related to TCM and natural medicines in some countries and regions were retrieved, the official websites of drug regulatory agencies were browsed, and pharmacovigilance regulatory agencies, related responsibilities, and regulatory content of TCM and natural medicines in various countries and regions were analyzed. Results Pharmacovigilance of TCM and natural medicines was specified in the pharmacovigilance system in many countries and regions. The European Union, India and other countries had established related regulatory agencies and worked out specific regulatory documents for TCM and natural medicines, but related pharmacovigilance systems were still under construction. Conclusion The pharmacovigilance of TCM and natural medicines has become an important part of pharmacovigilance in various countries and regions. The pharmacovigilance system of TCM and natural medicines in China is relatively complete compared with other countries and regions. China should keep up with the development of pharmacovigilance in various countries to motivate sustained research on pharmacovigilance of TCM and natural medicines and boost the development of global pharmacovigilance systems of TCM and natural medicines.

Key words: international, pharmacovigilance, European, American, natural medicines, United Kingdom, Oceania, Asian, traditional Chinese medicine (TCM)

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