中方ISO中医药国际标准申报现状分析及建议

Analysis and Suggestions on Application Status of Chinese ISO International Standards for Chinese Medicine

目的系统分析国际标准化组织/中医药技术委员会(ISO/TC 249)中医药国际标准国内申报现状,探讨存在的问题并提出建议。方法收集ISO/TC 249国内技术对口单位历年中方ISO/TC 249中医药国际标准申报材料,提取各标准申报项目提案的标准名称、申报年度、制定机构、所属工作组等信息并进行描述性统计分析。结果共收集276项中方ISO/TC 249中医药国际标准,自2010年首次申报,中医药国际标准数量即实现快速增长,至今虽增长趋于平缓,但申报数量仍逐年递增;中医药国际标准以原材料和传统加工的质量和安全工作组(WG1)申报项目数量最多,电子医疗设备联合工作组(JWG6)申报项目数量最少,各工作组间申报数量差异较大;标准申报单位多集中在高等院校和科研院所,企业和学会团体申报数量较少;中药材类国际标准申报仅有74味,占清单总数的20.22%;在项目审核中主要存在申报基础薄弱、制定的必要性不足和材料提交不全等质量问题。结论中医药国际标准申报中仍存在诸多问题,应积极做好应对策略,完善标准申报渠道,进一步推进中医药国际标准化工作。

Objective Systematically interpretating the present situation of application of International Organization for Standardization/Technical committee 249(ISO/TC 249)international standards of traditional Chinese medicine(TCM)in China,to investigate the existing issues and propose countermeasures.Methods Based on the applicated materials of Chinese ISO/TC 249 international standard of traditional Chinese medicine from the domestic technical corresponding department office of ISO/TC 249 each year,collect the standard name,application year,draught department,working group,and other required information of the proposal of each standard application,and provide descriptive statistical analysis.Results A total of 276 Chinese ISO/TC 249 international standards for traditional Chinese medicine were collected.In 2010,the number of maiden application has boosted dramatically.Although the acceleration has reduced recently,the number of applications still continued to increase year by year.The international standard of traditional Chinese medicine mostly applicated by Quality and Safety of Raw Materials and Traditional Processing Working Group(WG1),and least applicated by Joint IEC/TC 62-ISO/TC 249 WG Working Group(JWG6),and the application number difference between each working groups varies greatly.Most application came from the colleges,universities and research institutes,and enterprises and social groups contributed far less.There were only 74 types of Chinese herbal medicines among the applicated,as for 20.22%of the total list.The major problems affected the quality were unachievable technical foundation,unmeaningful application and missing materials.Conclusion There are many problems in the application of international standards for traditional Chinese medicine,Therefore,we should actively find solution and improve the application method to promote the standardization of international standards of traditional Chinese medicine.