Overview and reflections on the drug registration management systems of China,the United States,Japan and European Union
DING Xiaoli
LI Mengjiao
TAN Liyuan
YAO Shangchen
CHEN Hua
SUN Huimin
Abstract：Objective To provide international references for optimizing and improving the drug registration management system of China.Methods The drug registration management systems of China,the United States,Japan and the European Union,were summarized and analyzed systematically,including the regulatory authorities,law and regulations and registration procedures.Results The drug registration management system of China should be implemented in terms of law and regulations,review and approved process and efficiency,international coordination.Conclusion Global drug regulation is showing a trend of scientific,international and efficient development.It is suggested that China should build a more efficient and authoritative drug registration management by drawing on the international management experience.which can provide institutional support for safeguarding public health rights and high-quality development of the pharmaceutical industry.
Keywords：Drug registrationRegulatory authoritiesLaw and regulationsRegistration procedureEfficient and authorityHigh-quality development
Publication Date：2025-12-30
Online Publishing Date：2026-01-22(First online date of this platform, not the publication date of the document)
Pages：6( 1188-1193 )