Pharmacovigilance of Herbal and Traditional Medicines

  • Li Zhang
Part of the Methods in Pharmacology and Toxicology book series (MIPT)


This chapter first differentiates the concepts of traditional/complementary medicine and their products. It then briefly introduces the supervision and management systems of the China Food and Drug Administration and the differences between conventional medicine and traditional/complementary medicine products, taking drugs used in traditional Chinese medicine as an example. The chapter analyzes and discusses the global use of and regulatory environment for complementary and integrated medicine, and reviews the current methodological approaches to pharmacovigilance for herbal drugs and traditional medicines. Therefore throughout this chapter are showcased the challenges associated with such products and their rational uses, and the imperfections in the global supervision of such medicines in terms of both the methodology behind monitoring by the spontaneous reporting system (SRS) and additional pharmacovigilance. Finally, suggestions are proposed for measures to enhance pharmacovigilance of herbal and traditional medicines.

Key words

Pharmocovigilance Herbal and traditional medicine (H&TM) Traditional Chinese medicine (TCM) Spontaneous reporting system (SRS) Active surveillance Post-authorization safety study (PASS) 


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Li Zhang
    • 1
  1. 1.Department of Scientific ResearchDongfang Hospital, Beijing University of Chinese MedicineBeijingPeople’s Republic of China

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