In December, 2004, the Standardization Administration of China (SAC) has approved the establishments of three National Standardization Technical Committees. They are the National Standardization Technical Committees f...In December, 2004, the Standardization Administration of China (SAC) has approved the establishments of three National Standardization Technical Committees. They are the National Standardization Technical Committees for Environmental Protection Products (SAC/TC275), for Safety Management of Agricultural Transgenic Biology (SAC/TC276) and for Testing of New Varieties of Plant (SAC/TC277).The National Standardization Technical Committee for Environmental Protection Products is responsible for the development and revision of national standards in the following fields:展开更多
Objective： To review the current situation and progress of traditional Chinese medicine（TCM） international standards, standard projects and proposals in International Organization for Standardization（ISO）/technic...Objective： To review the current situation and progress of traditional Chinese medicine（TCM） international standards, standard projects and proposals in International Organization for Standardization（ISO）/technical committee（TC） 249. Methods： ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group（WG）, current stage and classification. Results： In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fields, 7 groups and sub-groups based on International Classification Standards. Conclusion： A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.展开更多
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
Forensic science is crucial for the administration of justice and case investigation.in China,political-legal organizations,including the courts,public security,procuratorate,and judicial administration,developed thei...Forensic science is crucial for the administration of justice and case investigation.in China,political-legal organizations,including the courts,public security,procuratorate,and judicial administration,developed their own forensic practices before 2004.As a result,the frequent and repeated appraisals undermined judicial authority and credibility.Thus,a law was published in 2005 to improve the uniform forensic management system by the Standing Committee of the National People’s Congress,leading to the establishment of the Forensic Administration of the Ministry of Justice in 2006.During this process,the increased accreditation and interflow highlighted the role of consensus in forensic standards for forensic service providers to avoid uncertainty regarding the methods used and interpretation of results.in 2017,a policy document was promulgated again to strengthen the importance of the uniform standards,which also proposed to establish a new national technical committee for the standardization of forensic science by the General Office of the State Council.in 2018,despite the continuing problems concerning uniformity,the Forensic Administration of the Ministry of Justice was merged into the Public Legal Services Administration.Yet,there is still a long way to go for the national technical committee for the standardization of forensic science.This paper analyses the evolution of forensic standards internationally and nationally,discusses the existing problems,and proposes relative solutions.Moreover,it discusses the future of standards development with the deepening of the reformation of both the national standardization and judicial system.展开更多
文摘In December, 2004, the Standardization Administration of China (SAC) has approved the establishments of three National Standardization Technical Committees. They are the National Standardization Technical Committees for Environmental Protection Products (SAC/TC275), for Safety Management of Agricultural Transgenic Biology (SAC/TC276) and for Testing of New Varieties of Plant (SAC/TC277).The National Standardization Technical Committee for Environmental Protection Products is responsible for the development and revision of national standards in the following fields:
基金Supported by the State Administration of Traditional Chinese medicine of China(No.ZZYZK2013-Guohesi A)China Academy of Chinese Medical Sciences(No.Z0243,No.Z0411)
文摘Objective： To review the current situation and progress of traditional Chinese medicine（TCM） international standards, standard projects and proposals in International Organization for Standardization（ISO）/technical committee（TC） 249. Methods： ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group（WG）, current stage and classification. Results： In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fields, 7 groups and sub-groups based on International Classification Standards. Conclusion： A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.
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.
基金This study was supported by grants from the Ministry of Justice[grant number 20SFB4017]the Shanghai science and Technology Innovation Fund[grant number 19DZ2201400]State Administration for Market Regulation[grant number 2019MK139].
文摘Forensic science is crucial for the administration of justice and case investigation.in China,political-legal organizations,including the courts,public security,procuratorate,and judicial administration,developed their own forensic practices before 2004.As a result,the frequent and repeated appraisals undermined judicial authority and credibility.Thus,a law was published in 2005 to improve the uniform forensic management system by the Standing Committee of the National People’s Congress,leading to the establishment of the Forensic Administration of the Ministry of Justice in 2006.During this process,the increased accreditation and interflow highlighted the role of consensus in forensic standards for forensic service providers to avoid uncertainty regarding the methods used and interpretation of results.in 2017,a policy document was promulgated again to strengthen the importance of the uniform standards,which also proposed to establish a new national technical committee for the standardization of forensic science by the General Office of the State Council.in 2018,despite the continuing problems concerning uniformity,the Forensic Administration of the Ministry of Justice was merged into the Public Legal Services Administration.Yet,there is still a long way to go for the national technical committee for the standardization of forensic science.This paper analyses the evolution of forensic standards internationally and nationally,discusses the existing problems,and proposes relative solutions.Moreover,it discusses the future of standards development with the deepening of the reformation of both the national standardization and judicial system.
