监管科学发展下药品审批提效的实践探讨  

Practices of Improving Efficiency in Drug Approval Under the Regulatory Science

作　　者：王刚 曾亚莉 雷灿 黄庭颖 Magda Bujar Ting Wang WANG Gang;ZENG Ya-li;LEI Can;HUANG Ting-ying;Magda Bujar;Ting Wang(Clarivate Analytics Information Services(Beijing)Company Ltd.;Centre for Innovation in Regulatory Science)

机构地区：[1]科睿唯安信息服务(北京)有限公司 [2]国际监管科学创新中心(CIRS)

出　　处：《中国食品药品监管》2021年第7期34-41,共8页China Food & Drug Administration Magazine

摘　　要：药品监管科学研究在最近10年取得了长足的发展。不管是从研究论文的产出,还是监管机构的法规以及指南文件的及时发布,均体现了顺应当前科技发展的需求。面对持续增长的审评压力,监管机构在资源有限的情况下,通过设置监管促进路径、开启共享审评模式等方式,提高审评效率,加速新药上市。展望未来的药品审评审批发展,将始终坚持以患者为中心的宗旨,全面考虑和平衡多个利益相关方的诉求,从而真正加速并优化创新产品从法规审评到患者可及的全流程。There is significant progress in the research of drug regulatory science in the last ten years.Both the output of research articles and the timely publication of regulations and guidance reflect the demands of adaption to current rapid development of science and technologies in pharmaceutical industry.With increasing review pressure and limited resources,global regulatory agencies have leveraged facilitated regulatory pathways and shared review mode to improve the review efficiency and accelerate the approval of new drugs.Drug regulatory review in the future should adhere to the principle of patient-centricity,comprehensively balance the demands from multiple stakeholders,so as to optimize and truly accelerate the whole process of innovative drugs from regulatory review to patient affordable access.

关 键 词：监管审评 监管科学 共享审评模式 监管促进路径 卫生技术评估 

分 类 号：R95[医药卫生—药学]