摘要
目的:研究美国FDA最小负担原则及应用,为我国医疗器械注册审评和科学监管提供参考。方法:通过文献研究,对2019年2月5日美国发布的《最小负担规范:概念和原则》(更新版)及其引用、关联的指导原则进行了分析。结果:最小负担原则是“用最少量的必要信息,在适当的时间、以最有效的方式,恰当地解决相关监管问题或事项”,具体原则主要为7条,旨在保证医疗器械监管标准不降低的情况下,科学配置监管资源,提升医疗器械监管效率。结论:应用最小负担原则有利于推行我国医疗器械审评审批制度改革:减轻审评负担,将有限的审评审批资源聚焦在高风险医疗器械产品,通过最有效的方式、在最恰当的时机、利用最少量的必要信息进行有效监管,更好地促进高质量、安全、有效和经济的创新医疗器械产品快速应用到临床,满足患者需求。建议从充实监管科学和审评科学体系、立法支持、制定补正通知书的指导原则、提升医疗器械标准在全生命周期监管中的作用和研究争议与监督5个方面推行具有中国特色的最小负担原则。
Objective:This article aims to study the Least Burdensome Provisions on medical device by the FDA,and offer reference for medical device regulation in China.Methods:Based on literature study,an analysis is carried out on the Least Burdensome Provisions which was published on 15 Feb,2019,and other relevant guidance and documents.Results:The Least Burdensome Provisions are defined as“the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time”,which consist of seven principles.The aim is optimizing resources and improving regulatory efficiency,without lowering regulatory standards.Conclusions:The application of the Least Burdensome Provisions will help NMPA to fulfill its responsibility of protecting public health by ensuring the safety and effectiveness of medical devices.In order to promote the Least Burdensome Provisions with Chinese characteristics,five suggestions are offered,including:improving the regulatory system,enhancing legislation,developing guidance for suggested formats of responding to deficiencies,stressing the role of medical device standards in total life cycle management,and setting up mechanism for dispute resolution.
出处
《中国食品药品监管》
2021年第1期48-57,共10页
China Food & Drug Administration Magazine
基金
国家药品监督管理局医疗器械标准管理中心课题(HT201902142)。
关键词
医疗器械
FDA
最小负担原则
注册审评
监管科学
全生命周期
medical device
FDA
Least Burdensome Provisions
premarket approval
regulatory science
total life cycle
