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Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica

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Abstract

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

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Authors and Affiliations

  1. School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China

    Jing-yi Yang & Rui Wang

  2. Institute of Traditional Chinese Medicine International Standardization, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China

    Zhen Sang

  3. Institute of Traditional Chinese Medicine International Standardization, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China

    Yan-hong Shi & Yi-ran Huang

Authors
  1. Jing-yi Yang
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  2. Zhen Sang
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  3. Rui Wang
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  4. Yan-hong Shi
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  5. Yi-ran Huang
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Contributions

Yang JY and Shi YH drafted the manuscript and prepared the tables and figure. San Z and Wang R contributed to the critical revisions of the manuscript. Huang YR, as corresponding author, and Shi YH designed the study and developed the manuscript. All authors read and approved the final manuscript for publication.

Corresponding author

Correspondence to Yi-ran Huang.

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Conflict of Interest

All authors declared no conflict of interests regarding the publication of this paper.

Supported by the National Social Science Fund of China (No. 19CGJ037), Three-Year Action Plan for Development of Traditional Chinese Medicine in Shanghai [No. ZY(2021–2023)-0212], Shanghai Association for Science and Technology (No. 20DZ2200800), Shanghai University of Traditional Chinese Medicine Xinglin Talent Plan

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Yang, Jy., Sang, Z., Wang, R. et al. Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica. Chin. J. Integr. Med. 29, 540–548 (2023). https://doi.org/10.1007/s11655-022-3526-7

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  • DOI: https://doi.org/10.1007/s11655-022-3526-7

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