Research and consideration on electronic submission system for drug registration in foreign countries
YIN Cui-xiang
LI Hai-ling
ZHANG Yuan
Abstract：With the continuous development of information technology in drug regulation,countries such as the United States,the European Union,and Japan have established electronic submission systems by integrating information technology and drug registration to enable online submission and reception,promote the deepening and implementation of the reform to the drug review and approval system,and enhance service level through website integration and public information.This paper studies the functions and characteristics of the electronic submission systems in the United States,the European Union,Japan and other countries,in order to provide reference for the informatization construction of drug registration electronic submission in China,promote the efficiency of electronic submission,increase quality and speed of review and approval,and strengthen the service efficiency of drug regulation by"internet plus".
Keywords：drug registrationelectronic submissioninformation technologyinternet plusdrug regulation
Publication Date：2025-05-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：3( 1032-1034 )