美国药品审评质量管理规范评介及对我国的启示.pdf

Chinese Journal of Health Policy, February 2015,Vol． 8 No． 2 ·药物政策· 美国药品审评质量管理规范评介及对我国的启示 耿晓雅? 邵 蓉 　 　 中国药科大学国际医药商学院 江苏南京 　 　 211198 摘 要 本文采用文献研究法,在概述美国药品审评质量管理规范的政策背景、发展历史和现状的基础 【 　 】 上,重点介绍其为实现政策目标而采取的相应措施,并以 — 年美国药品审评时间中位数和首轮药品 1993 2013 批准率数据来说明其实施效果。 研究认为,一套科学完善的药品审评质量管理规范可有效保证药品审评质 量、提高药品审评效率。 然而目前我国药品审评质量管理规范还不完善,建议通过细化我国药品审评时限规 定、制定可操作性强的审评模板、重视药品审评质量管理规范体系的相关培训和持续改进等措施进一步完善 我国药品审评质量管理规范。 【关键词】 美国; 药品审评; 药品审评质量管理规范 中图分类号: 文献标识码: : R197　 A　 doi 10． 3969 / j． issn． 1674-2982． 2015． 02． 010 Evaluation on good review practice in the United States of America and its implications for China GENG Xiao-ya SHAO Rong , International Pharmaceutical Business School China Pharmaceutical University Nanjing Jiangsu 211198 China , , , Abstract 【 】 The paper summarizes the background, development history and current state of good review prac- tice (GRP) in the United States of America. On this basis, the paper then focuses on measures for the realization of GRP policy objective and introduces the effects of GRP by using the statistical data of the median time to application approval and approval rates of New drug applications(NDAs) and Biological License Applications(BLAs) on the first cycle. Through research, the paper considers a set of scientific and comprehensive GRP that can effectively guarantee the quality of drug reviews and improve the efficiency of drug reviews. However, China’s GRP is not complete yet. So it also suggests that improving GRP in China further by detailing the timeline of drug review in China, developing workable review templates, emphasizing tr