浅析中美药械组合产品的监管对策

摘要

通过汇总2009～2013年组合产品办公室（ OCP）向美国国会提交的组合产品年度报告中的数据，分析近年来美国食品和药物管理局（ FDA）组合产品的申报情况，并研究FDA对药械组合产品的监管模式，汇总分析2009～2014年我国药械组合产品属性界定的申请情况，总结中美两国对药械组合产品监管上的区别，分析我国药械组合产品监管中存在的问题，为加强此类产品的监管工作提供参考。%This paper summarizes the datas in the annual office of combination products( OCP) performance report to American con-gress from 2009 to 2013,analysis the attribute conditions to the combination products designation in the recent years of US.Studies the u-nited states′supervision mode on such products.Summarizes and analysis the attribute conditions to the drug and medical device combina-tion products designation from 2009 to 2014.Summarizes the differents in the management of combination products between the two coun-tries and the problems in our country, to provide some certain references for strengthening such products′supervision work.