The application of European Public Assessment Reports in the identification of reference medicinal products for generic medicinal products
XU Ming-di
NIU Jian-zhao
YANG Dong-sheng
LI Tao
QIAO Li-tao
GAO Tian-tian
Abstract：The European Public Assessment Reports are evaluation reports published by European Medicines Agency (EMA) or relevant national health authority for every human medicine application that has been granted a marketing authorization.It is published after removing the confidential information of the applicant and should be updated periodically after the revision or amendment of the application to reflect the latest regulatory information on the medicine.The composition of the European Public Assessment Reports is briefly described,and examples are given to introduce the application of the information contained in the regulatory documents such as public assessment reports,summary of product characteristics and package leaflet in the selection,identification and purchasing of reference medicinal products used in the marketing authorization application of generic medicinal products in the European Union (EU),aiming to provide important supporting information to assist the domestic pharmaceutical enterprises to submit their marketing authorization application to the EU.
Keywords：public assessment reportssummary of product characteristicspackage leafletreference medicinal productgeneric medicinal product
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( 2924-2927 )