摘要
目的 为完善我国医疗器械可及性制度提出建议。方法 分析我国医疗器械可及性的影响因素及相关制度发展现状,就制度发展提出建议。结果 在紧急情形下影响医疗器械可及性的主要因素有新产品的快速审批和未上市产品的直接使用。目前,以审批方式实现可及性的相关制度有医疗器械应急审批、优先审批、创新医疗器械特别审查、附条件审批等,非审批方式有医疗器械拓展性应用和医疗器械紧急使用授权制度。现有方式实现可及性,存在制度定位与紧急情形不完全匹配、制度路径不足以应对紧急情形、制度手段不能满足紧急情形需要等不足。结论 我国现行制度在应对突发事件等紧急情形时,不能完全解决医疗器械可及性问题。建议医疗器械可及性相关制度上升到法律层面并完善相关细则。
Objective To provide suggestions for improving the accessibility system of medical devices in China.Methods The factors affecting the accessibility of medical devices and the current development status of relevant systems in China were analyzed,and suggestions for the development of systems were put forward.Results The main factors affecting the accessibility of medical devices in emergencies included the rapid approval of new products and direct use of products not launched.At present,the relevant systems of medical devices for realizing accessibility through approval included the emergency approval,priority approval,special review of innovative medical devices,conditional approval and so on;while the relevant systems for realizing accessibility not through approval included the expansion application and authorization systems for emergency use.The present systems for realizing accessibility had some shortcomings such as incomplete matching of system positioning with emergencies,imperfect system paths to respond to emergencies and inadequate means to meet the needs of emergencies.Conclusion The present system in China cannot completely solve the accessibility problem of medical devices when dealing with emergencies.It is suggested that the relevant systems of medical device accessibility should be legal,and the relevant detailed rules should be improved.
作者
李晶
LI Jing(National Medical Products Administration Institute of Executive Development,Beijing,China 100073)
出处
《中国药业》
CAS
2023年第22期30-34,共5页
China Pharmaceuticals
基金
国家重点研发计划课题[2018YFC1603703-01]。
关键词
医疗器械
可及性
审评审批制度
突发事件
药品监管
medical device
accessibility
review and approval system
emergency
drug administration
