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Pharmacovigilance of Herbal and Traditional Medicines

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Evidence-Based Pharmacovigilance

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

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.

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Author information

Authors and Affiliations

  1. Department of Scientific Research, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, 100078, People’s Republic of China

    Li Zhang

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  1. Li Zhang
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Editors and Affiliations

  1. Epidemiology Group Lead, Analytics, Worldwide Safety and Regulatory, Tadworth, Surrey, UK

    Andrew Bate

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Zhang, L. (2018). Pharmacovigilance of Herbal and Traditional Medicines. In: Bate, A. (eds) Evidence-Based Pharmacovigilance. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8818-1_3

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  • DOI: https://doi.org/10.1007/978-1-4939-8818-1_3

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-8816-7

  • Online ISBN: 978-1-4939-8818-1

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