摘要
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。
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.
作者
陈坚生
李杨玲
陈旻
谢志洁
吴生齐
CHEN Jiansheng;LI Yangling;CHEN Min;XIE Zhijie;WU Shengqi(Food and Cosmetics Department of Guangdong Drug Administration Evaluation and Certification Center,Guangzhou,Guangdong 510080,China;Science and Technology Department of Guangdong Medical Device Quality Supervision and Test Institute,Guangzhou,Guangdong 510663,China;Equipment Management Department of Guangdong Institute for Drug Control,Guangzhou,Guangdong 510663,China;Guangdong Medical Products Administration,Guangzhou,Guangdong 510080,China)
出处
《今日药学》
CAS
2024年第2期151-155,共5页
Pharmacy Today
基金
广东省药品监督管理局2021年科技创新项目(2021TDZ01、2021TDZ02、2021TDZ03、2021TDZ04)。
关键词
药品监管
技术支撑
机构
能力建设
标准
medical products administration
technical support
institution
capacity building
standards
