The introduction of the reference medicinal products for marketing authorisation application of generic medicinal products in the EU
XU Ming-di
NIU Jian-zhao
YANG Dong-sheng
LI Tao
QIAO Li-tao
GAO Tian-tian
Abstract：It is vital to choose the right reference medicinal products during the research & development of generic medicinal products.It is clearly specified in the relevant documents issued by the China Food and Drug Administration (CFDA) that the reference medicinal products used for the re-evaluation of generic medicinal products or the application for generic medicinal products should be innovative products or internationally recognized medicinal products of the same class.To facilitate the Chinese pharmaceutical enterprises choose and identify the reference medicinal products,detailed descriptions of the four medicinal product evaluation procedures,i.e.,centralized procedure (CP),decentralised procedure (DCP),mutual recognized procedure (MRP) and national authorization procedure (NP),are provided in this article as well as the methods and procedures,including the community register,MRI product index and approved drug products list of each member state of the European Union (EU),for identifying the reference medicinal products used in the generic medicinal product application in the EU.
Keywords：re-evaluation of generic medicinal productreference medicinal productEuropean Medicines Agency (EMA)centralized procedurecommunity register
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2933-2936 )