Generic drug labeling management of FDA and EMA
GAO Li-li
LI Min
WANG Yu-zhu
LI Rui-feng
YANG Jin-bo
Abstract：Drug products are very special commercial products,and their labelings are important to instruct both patients and doctors to use the drugs safely and effectively.This article addresses the management requirements of FDA and EMA for generic drug products to help the readers know the regulation concepts of foreign authorities from perspectives of regulation,management department,content and format,and brings inspirations for the generic drug labeling management in China.
Keywords：generic drugdrug labelingFDAEMA
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：5( 2903-2907 )