浅谈中美两国药械组合产品的监管对策

浅谈中美两国药械组合产品的监管对策

王海燕

国家食品药品监督管理总局行政事项受理服务和投诉举报中心

收稿日期:2015-05-11 修回日期:2015-05-23 出版日期:2015-06-25 发布日期:2015-06-25

Supervisory Measures of Combination Products in Sino US

the Acceptance Service of Administrative Matters and Complaint Report Center of CFDA

Received:2015-05-11 Revised:2015-05-23 Online:2015-06-25 Published:2015-06-25

摘要/Abstract

摘要： 本文通过汇总2009—2013年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FDA组合产品的申报情况，并研究美国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管理上的区别及我国目前管理上存在的问题，为我国加强对此类产品的监管工作提供参考。

Abstract: This paper summarizes the datas in the annual OCP Performance Report to American congress from 2009 to 2013,analysis the attribute conditions to the combination products designation in the recent years of US;studies the united states'supervision mode on such products;summarizes and analysis the attribute conditions to the drug and medical device combination products designation from 2009 to 2014;summarizes the differents in the management of combination products between the two countries and the problems in our country, to provide some certain references for strengthening such products’ supervision work.

王海燕. 浅谈中美两国药械组合产品的监管对策[J]. .

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