中国药房2017，Vol.28Issue(10)：1302-1306,5.DOI:10.6039/j.issn.1001-0408.2017.10.02
美国生物制品数据保护制度的立法演变与成因分析
Analysis of the Legislative Evolution and Causes of Biologics Data Protection System in the United States
摘要
Abstract
OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's first"strong protection"standard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.关键词
生物制品数据保护/立法演变/制度成因/美国Key words
Biologics data protection/Legislative evolution/Causes of the system/United States分类
医药卫生引用本文复制引用
姚雪芳,丁锦希,任宏业..美国生物制品数据保护制度的立法演变与成因分析[J].中国药房,2017,28(10):1302-1306,5.基金项目
国家社会科学基金资助项目(No.13BFX120) （No.13BFX120）
国家食品药品监督管理总局委托研究项目 （）
2015年华海药业研究生创新基金项目(No.1010030004) （No.1010030004）
