首页|广东省药品监管技术支撑机构能力建设标准构建的探析

广东省药品监管技术支撑机构能力建设标准构建的探析

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目的 建立能适用于各种类型的药品监管技术支撑机构能力建设标准。方法 从资源、技术、服务及创新4个层面探索构建药品监管技术支撑机构能力建设标准的指标体系,基于该标准对广东省药品监管技术支撑机构开展对标调查。结果 本文建立的能力建设标准包含16个二级指标及35个指标要求,结果表明所构建的能力建设标准相对客观合理,具有一定的指导和促进作用。结论 该能力建设标准可指导药品监管技术支撑机构开展主动对标和能力建设活动,亦可作为监管机构开展能力考评的标准,为加快提升技术支撑机构能力提供科学依据。
Analysis on the Construction of Capacity Building Standards for Technical Support Institutions of Guangdong Medical Products Administration
OBJECTIVE To establish the capacity building standards of technical support institutions of Guangdong Medical Products Administration(GDMPA)which can be applied to various types.METHODS The index system of capacity building standards for technical support institutions of GDMPA was explored and constructed from 4 levels of resources,technology,service and innovation.Based on the standard,a benchmarking survey was conducted on the capacity building of technical support institutions of GDMPA.RESULTS The capacity building standards establishment in this paper included 16 second-level indicators and 35 index requirements.The setting of each index project was relatively scientific and reasonable,and had certain guidance and promotion effect.CONCLUSION The capacity building standard can guide the technical support institutions to carry out active benchmarking and capacity building activities,and also can be used as a standard for building and carrying out capacity evaluation,and provide scientific basis for accelerating the improvement of technical support institutions.

medical products administrationtechnical supportinstitutioncapacity buildingstandards

陈坚生、李杨玲、陈旻、谢志洁、吴生齐

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广东省药品监督管理局审评认证中心,广东广州 510080

广东省医疗器械质量监督检验所,广东广州 510663

广东省药品检验所,广东广州 510663

广东省药品监督管理局,广东广州 510080

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药品监管 技术支撑 机构 能力建设 标准

广东省药品监督管理局科技创新项目(2021)广东省药品监督管理局科技创新项目(2021)广东省药品监督管理局科技创新项目(2021)广东省药品监督管理局科技创新项目(2021)

2021TDZ012021TDZ022021TDZ032021TDZ04

2024

今日药学
广东省药学会 中国药学会

今日药学

影响因子:0.413
ISSN:1674-229X
年,卷(期):2024.34(2)
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