FDA与EMA对纳米药物开发的技术要求与相关指导原则  

Technical requirements and related guidelines of the nanodrugs in FDA and EMA

作　　者：何伍[1] 杨建红[1] 王海学[1] 李学明[2] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]南京工业大学药学院,南京211816

出　　处：《中国新药杂志》2014年第8期925-931,共7页Chinese Journal of New Drugs

摘　　要：随着纳米技术在医药领域的广泛应用,对纳米药物的研究越来越多。美国FDA及欧盟EMA在纳米药物的研发、应用及监管方面积累了一些经验,并颁布了一系列规范及相关指导原则,从而保证了纳米药物安全有效可控。相比之下,我国在纳米药物领域起步较晚,纳米药物在研发、监管与安全性评价方面的指导原则欠缺。本文介绍了美国FDA及欧盟EMA对纳米药物开发的技术要求与相关指导原则,以期为我国纳米技术药物及材料的发展提供有益参考。With the wide application of nanotechnology in the field of medicine, more and more research of nanodrugs is being carried out. FDA and EMA have accumulated some experiences of research, development, ap- plication and regulation in the field of nanodrugs. Besides, a series of specifications and related guidelines have been promulgated to ensure the safety of nanodrugs. By contrast, research and development of nanodrugs started late in our country, and supervision and guidance on the safety evaluation principle are lacked. This paper intro- duces the technical requirements and the related guidelines of nanodrugs in FDA and EMA, so as to provide the beneficial reference for the development of nanodrugs and nannomaterials in our country.

关 键 词：纳米药物 美国食品药品监督管理局 欧洲药品管理局 技术要求 监管 

分 类 号：R95[医药卫生—药学]