美国突破性治疗(BTD)程序实施对我国的启示  

Implementation of Breakthrough Therapy designation in the United States and its enlightenments to China

作　　者：胡一琳 赵晓佩[1] 马美英 张梦瑶 HU Yilin;ZHAO Xiaopei;MA Meiying;ZHANG Mengyao(School of Medical Humanities,Capital Medical University,Beijing 100069,China;Cancer Hospital Chinese Academy of Medical Sciences,Beijing 100021,China)

机构地区：[1]首都医科大学医学人文学院,北京100069 [2]中国医学科学院肿瘤医院,北京100021

出　　处：《卫生软科学》2023年第12期85-88,共4页Soft Science of Health

基　　金：北京市社会科学基金(19FXB005)。

摘　　要：文章对美国突破性疗法的适用程序进行研究,总结归纳该程序的特点及优势。在此基础上,提出我国“突破性治疗药物”程序可以采取建立多元化沟通交流制度、确立强制性专家咨询会制度、明确药审机构主动指导职责等措施来完善,在保证抗肿瘤药物安全有效的基础上加快药物审评速度,提高药物上市许可申请审评通过率。In this paper,the application procedures of Breakthrough Therapy designation in the United States are studied,and the characteristics and advantages of the procedures are summarized.On this basis,it is proposed that“breakthrough therapy designated drugs”can be improved by establishing a diversified communication system,a mandatory expert consultation system,and clarifying the responsibilities of active guidance of drug evaluation institutions.On the basis of ensuring the safety and effectiveness of anti-tumor drugs,the speed of drug evaluation should be accelerated,and the approval rate of technical review of applications for drug marketing authorization should be improved.

关 键 词：突破性疗法 新药审评 突破性治疗药物程序 

分 类 号：R194[医药卫生—卫生事业管理]