美国FDA组合式医药产品监管现状简析

Discussion on the regulation of combination products by FDA

本文通过对美国组合式医药产品的监管模式进行研究,为我国完善组合式医药产品的监管提供参考。文章主要采用文献研究和数据分析法,通过查阅相关文献以及检索FDA官方网站查找相关文件与法规,统计2011-2016年组合产品办公室(OCP)年度报告中的数据,分析近年来组合式医药产品的申报与审评情况,对美国组合式医药产品的监管策略进行研究。研究发现,美国对组合式医药产品的管理在法律法规体系建立、机构设置、产品申请和审查程序及标准等方面相对完善,值得我国对加强组合式医药产品监管的学习与借鉴。

This paper studies the regulatory model of the United States for combined pharmaceutical products and provides reference for improving the supervision of combined pharmaceutical products in China.Literature research and data analysis were conducted.Relevant literature was consulted,and the official website of FDA was retrieved to find related documents,laws and regulations,the data in the annual reports of the Combination Products Office(OCP)in 2011-2016 were summarized,the application and review of combined pharmaceutical products in recent year were analyzed,and the regulatory strategy of the United States for combined pharmaceutical products was researched.It was found that the management of combined pharmaceutical products by the United States is relatively perfect in terms of the establishment of laws and regulations,setting of institutions,application and examination procedures,and standards of products,which is worth learning by China to strengthen the supervision of combined pharmaceutical products.