Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

欧盟仿制药参比制剂检索与确认简介（英文）

It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.

参比制剂的选择是仿制药开发和研究的一个重要环节。国家食品药品监督管理总局相关公告明确了用于仿制药质量与疗效一致性评价或仿制药申请时的参比制剂应为原研药品或国际公认的同种药物。为了帮助国内外仿制药企业正确检索和确定欧盟的参比制剂,本文详细介绍了欧盟药品的四种审评方式及相应的上市产品目录。同时以检索仿制药米非司酮片(200mg)在欧盟上市申请时须选用的参比制剂为例,结合不同的上市产品目录详细介绍了检索和确定欧盟仿制药的参比制剂过程。