文章摘要
李颖,杨振,姚蕾,李丽莉,孙彬裕,张孝明.建立和完善“精准医疗”相关政策,促进体外诊断试剂产业创新与升级[J].中国药事,2019,33(9):1046-1050
建立和完善“精准医疗”相关政策,促进体外诊断试剂产业创新与升级
Establishing and Improving Related Policies for “Precision Medicine” to Promote the Innovation and Upgrade of in vitro Diagnostic Reagent Industry
投稿时间:2019-06-28  
DOI:10.16153/j.1002-7777.2019.09.014
中文关键词: 精准医疗  体外诊断试剂  创新体系
英文关键词: precision medicine  in vitro diagnostic reagent  innovation system
基金项目:
作者单位E-mail
李颖 中国食品药品检定研究院, 北京 100050  
杨振 中国食品药品检定研究院, 北京 100050 yangzhen@nifdc.org.cn 
姚蕾 中国食品药品检定研究院, 北京 100050  
李丽莉 中国食品药品检定研究院, 北京 100050  
孙彬裕 中国食品药品检定研究院, 北京 100050  
张孝明 中国食品药品检定研究院, 北京 100050  
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中文摘要:
      目的:聚焦"精准医疗",探讨"精准医疗"工作中体外诊断试剂产业发展需求,以期促进我国"精准医疗"涉及的高端诊断医疗产品发展。方法:从我国"精准医疗"涉及的体外诊断试剂产业现状、创新体系以及相关技术等方面,分析体外诊断试剂产业发展面临的问题并提出相关建议,为发展"精准医疗"涉及的高端诊断试剂产业提供参考。结果与结论:随着我国"精准医疗"工作的开展,为高端诊断产品发展带来了机遇,同时也面临诸多挑战,如研发投入严重不足,创新体系配套政策欠缺,国家及行业标准制修订滞后等问题。应从加速配套政策建立、加强体外诊断试剂标准、质量管理体系建设等方面着手,提升我国"精准医疗"核心竞争力,推动诊断产品创新体系建设,促进体外诊断试剂产业发展。
英文摘要:
      Objective:To promote the development of high-end diagnostic medical products involved in "precision medicine" in China by focusing on "precision medicine" and exploring the development need of in vitro diagnostic reagent industry in "precision medicine". Methods:The problems faced by in vitro diagnostic reagent industry development were analyzed from the status quo, innovation system and related technology of in vitro diagnostic reagent industry involved in "precision medicine" in China, and made relevant suggestions so as to provide references for the development of high-end diagnostic reagent industry involved in "Precision medicine". Results and Conclusion:The development of "Precision medicine" in China has brought opportunities for the development of high-end diagnostic products but at the same time it has brought many challenges, such as serious shortage of investment in research and development, lack of supporting policies for innovation systems, as well as lags in the revision of national and industry standards. It is suggested that the establishment of supporting policies should be set up and the construction of in vitro diagnostic reagent standards and quality management systems should be strengthened to improve the core competitiveness of "precision medicine" and promote the construction of innovation system of diagnostic products and the development of in vitro diagnostic reagent industry of China.
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