疫苗国家监管体系评估中人力资源培训要求浅析与启示

Analysis and Enlightenment on the Requirements for Human Resource Training Indicators in the National Regulatory Authority Assessment for Vaccine

目的促进我国药品监管队伍培训体系的完善及药品监管能力的提升。方法结合2022年世界卫生组织(WHO)对疫苗国家监管体系评估(NRA)的情况,对WHO全球基准评估工具(GBT)各版块培训相关指标的需求进行梳理、解读,基于我国现有体系,对标GBT,分析我国药品监管队伍培训体系现况,并提出相关建议。结果与结论GBT分9个板块(共包括62项指标,268项亚指标),其中18个亚指标涉及培训相关要求。我国已基本建立较完善的药品监管人员培训体系,但与WHO要求相比仍有改进空间,对此,需进一步理顺国家级和省级教育培训工作的衔接机制,优化培训计划与能力框架的匹配,完善培训需求与培训效果评估的闭环;进一步进行监管科学研究,明确各岗位的能力要求,并研究相应的能力评估方法,打造以能力框架为导向的课程体系。进而不断健全培训体系,提升药品监管能力。

Objective To perfect the training system of Chinese drug regulation team,and to improve the ability of drug regulation.Methods Based on the National Regulatory Authority(NRA)assessment for vaccine by World Health Organization(WHO)in 2022,the relevant indicators of training in various sections of the WHO Global Benchmarking Tool(GBT)were summarized and interpreted.Based on the existing system in China and referring to the GBT,the current status of training system of Chinese regulation team was analyzed,and relevant suggestions were put forward.Results and Conclusion There were nine sections in GBT(including 62 indicators and 268 sub-indicators),of which 18 sub-indicators were related to the training requirements.Our country has basically established a relatively complete training system for regulatory personnel,but still leaving a lot to improve compared with the requirements of WHO.In this regard,in order to further perfect the training system and improve the ability of drug regulation,we should further smooth the linkage mechanism between national and provincial education and training work,optimize the matching of training plans and capability frameworks,and improve the closed-loop of training needs and assessment for training effect;we should further research on the regulatory science,clarify the competency requirements of each position,research on corresponding competency assessment methods,and create a curriculum system guided by competency framework.