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

YANG Jing-yi; SANG Zhen; WANG Rui; SHI Yan-hong; HUANG Yi-ran

doi:10.1007/s11655-022-3526-7

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

Regulation and Guideline | Updated：2023-05-25

- Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica
- Chinese Journal of Integrative Medicine Vol. 29, Issue 6, Pages: 540-548(2023)
- Affiliations：
  
  1.School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
  2.Institute of Traditional Chinese Medicine International Standardization, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
  3.Institute of Traditional Chinese Medicine International Standardization, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
- Author bio：
  
  Mr. HUANG Yi-ran, E-mail: hyr@shutcm.edu.cn
- Funds：
- DOI：10.1007/s11655-022-3526-7
  CLC：
- Published：2023-06，
  
  Published Online：04 May 2022，
  
  Accepted：01 September 2021
Scan for full text
YANG Jing-yi, SANG Zhen, WANG Rui, et al. Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica. [J]. Chinese Journal of Integrative Medicine 29(6):540-548(2023)
DOI：

YANG Jing-yi, SANG Zhen, WANG Rui, et al. Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica. [J]. Chinese Journal of Integrative Medicine 29(6):540-548(2023) DOI： 10.1007/s11655-022-3526-7.

摘要

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.

关键词

Keywords

Chinese materia medicamedicinal plantsinternational standardsInternational Organization for StandardizationTechnical Committee of Traditional Chinese MedicineWorld Health Organization

references

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