日本临床研究推进计划及其实施效果对中国创新药物的启示  

Performance of clinical trials promoting project for development of new drugs in Japan and its enlightenment to China

作　　者：张邦禹 李玉平[2] 徐瑛[3] 周斌 ZHANG Bang-yu;LI Yu-ping;XU Ying;ZHOU Bin(China National Pharmaceutical Industry Information Center,China State Institute of Pharmaceutical Indusry,Shanghai 200040,China;Shanghai Pulmonary Hospial Afiliated to Tongji University,Shanghai 200433,China;Shanghai Center for Drug Fraluation and Inspection,Shanghai 201210,China)

机构地区：[1]中国医药工业研究总院,中国医药工业信息中心,上海200040 [2]同济大学附属上海市肺科医院,上海200433 [3]上海药品审评核查中心,上海201210

出　　处：《中国新药杂志》2020年第14期1561-1565,共5页Chinese Journal of New Drugs

摘　　要：日本医疗研究开发机构临床研究推进计划是为了加速日本基础研究转化水平,加快得到监管部门审批承认投入应用的计划。本文通过深入分析该计划,结合通过该计划资助获得批准的医药产品,探讨该项计划的实施效果。再通过我国国情和现有政策的分析,建议完善我国临床研究资助体系,加速创新药物上市。The Clinical Trials Promoting Project for Development of New Drugs of the Japan MedicalResearch and Development Agency was designed to accelerate the conversion speed of basic research and theapproval of the application of the program by regulatory authorities in Japan. This article explored the effectivenessof the program by in-depth analysis, combined with the approved pharmaceutical products funded by the program.Through the analysis of China’s national conditions and existing policies, it is suggested to improve China’s clinicalresearch funding system and accelerate the marketing of innovative drugs.

关 键 词：临床研究推进计划 创新药物 基础研究转化 

分 类 号：R95[医药卫生—药学]