Direction on the writing of labeling of in vitro diagnostic reagents regulated as drugs
JIA Yan-hua
YU Peng-li
WU Zhou-yi
JIA Dong-chen
Abstract：Drug labeling is an important technical document for the regulatory agency to approve the product,and its content includes information about the safety,effectiveness,and product quality related to the product.In vitro diagnostic reagents regulated as drugs refer to those have complete system of testing reagents,calibration products,quality control products,testing equipment,etc.,and are managed according to the batch issuance of biological products.In view of the fact that in vitro diagnostic products regulated as drugs are different from therapeutic and preventive biological products,neither the same with in vitro diagnostic reagents regulated as devices,suggestions are put forward on the format,content requirements and precautions of labeling of in vitro diagnostic products regulated as drugs referring to the relevant laws and regulations of China and the relevant requirements of the labeling of in vitro diagnostic reagents by EMA,FDA and other agencies,so as to provide reference for applicants or marketing authorization holders when writing labeling.
Keywords：in vitro diagnosticreagentsdrugmanagementlabeling
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 669-672 )