美日参比制剂目录的介绍与我国参比制剂目录遴选原则的探讨
Introduction of Orange Book in USA and Japan and discussion of the directory selection principle for reference formulations in China
分类号：
出版年·卷·期（页码）：2013,33 (11):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
美国和日本对参比制剂都有明确的规定，并建立了详细的参比制剂目录，也可称之为"橙皮书"，而在我国，尚未建立参比制剂目录。此次《国家药品安全"十二五"规划》仿制药质量一致性评价正好是我国药品参比制剂目录(橙皮书)建立的契机。本文对美国和日本参比制剂目录进行了介绍，进一步探讨如何在我国建立参比制剂目录，对参比制剂的遴选方式和遴选流程提出建议。
-----英文摘要：---------------------------------------------------------------------------------------
In the United States and Japan,there are detailed directories,which are refered to the"Orange Book",established for defined specifications of reference formulations for regulation,while such directories have not been established in China.It is an opportunity to set up"Orange Book"in our country with the launching of consistency evaluation of the quality of generic drugs during the program of"12th Five-Year Plan"for national drug safety.The contents of"Orange Book"in the United States and Japan were introduced and how to establish domestic"Orange Book"were discussed in this article and the selection approaches and selection procedures of reference formulations were suggested.
-----参考文献：---------------------------------------------------------------------------------------
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