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...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.展开更多
In order to push forward the research and development of innovative drugs,to re-exploit large species,and to invent healthy product,Tianjin Pharmaceutical Association
基金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)。
文摘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.
文摘In order to push forward the research and development of innovative drugs,to re-exploit large species,and to invent healthy product,Tianjin Pharmaceutical Association
