文章摘要
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 Perfecting Relevant Policies of "Precise Medical " to Promote the Innovation and Upgrading of In Vitro Diagnostic Reagent Industry
投稿时间:2019-06-28  修订日期:2019-08-22
DOI:
中文关键词: 精准医疗  体外诊断试剂  创新体系
英文关键词: precise medical  In vitro diagnostic reagent  Innovation system
基金项目:
作者单位邮编
李颖 中国食品药品检定研究院 100050
杨振* 中国食品药品检定研究院 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:从产业战略、产业政策、创新技术及质量安全等方面,剖析打造诊断产品创新体系的关键要素,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,质量体系存在问题。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,打造我国“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: Focus on “precise medical” and explore the development needs of in vitro diagnostic reagents industry in “precise medical” work, in order to promoting the development of high-end diagnostic medical products involved in “precise medical” in China. Method: From the aspects of industrial strategy, industrial policy, innovative technology and quality safety, the key elements of innovative system for diagnostic products are analyzed, to provide reference for the development of high-end diagnostic reagent industry involved in “precise medical”. Conclusion: With the development of "precise medical" work in China, it brings opportunities for the development of high-end diagnostic products, but also faces many challenges, such as serious shortage of investment in research and development, lack of supporting policies for innovation systems, lags in the revision of national and industry standards, and problems in the quality system. We should speed up the establishment of supporting policies, and strengthen the construction of in vitro diagnostic reagent standards and quality management systems, to build the core competitiveness of "precision medical" , promote the construction of innovation system of diagnostic products and the development of in vitro diagnostic reagent industry of China.
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