我国开展进口预防性疫苗国际多中心临床试验的必要性  

Analysis on the necessity of international multi-regional clinical trials of imported prophylactic vaccines in China

作　　者：黎泽琳 杨建红 董江萍 LI Ze-lin;YANG Jian-hong;DONG Jiang-ping(School of Business Administration,Shenyang Pharmaceutical University,Shenyang110016,China;School of Yeehong Business,Shenyang Pharmaceutical University,Beijing100055,China;Center for Food and Drug Inspection of National Medical Products Administration,Beijing100044,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]沈阳药科大学亦弘商学院,北京100055 [3]国家药品监督管理局食品药品查验中心,北京100044

出　　处：《中国新药杂志》2021年第21期1928-1933,共6页Chinese Journal of New Drugs

摘　　要：本文通过对比近20年在美国通过国际多中心临床试验(MRCT)路径获批疫苗的上市时间与在中国的上市信息,以选择代表性品种进行案例分析的方式系统地论述了中国开展疫苗国际多中心临床试验必要性,并分析了预防性疫苗临床试验管理策略和制度的优势,进一步提出了在我国落地实施的可行性建议。Based on comparison of the marketing time of vaccines approved through multi-regional clinical trials(MRCT)between the United States and China in the past 20 years,representative varieties were selected for case analysis.We systematically analyzed the necessity of conducting international MRCT of vaccines in China,and the system advantages and management strategy of prophylactic vaccine clinical trial,further providing suggestions on feasibility of putting it forward.

关 键 词：预防性疫苗 国际多中心临床试验 进口疫苗 

分 类 号：R95[医药卫生—药学]