Comparison and analysis of risk-based drug inspection between NMPA and US FDA
LI Yuan
ZHOU Gang
Abstract：In order to continue to explore and improve the working methods of risk-based drug inspection in China,this paper describes the institutions,regulatory documents and implementation procedures related to drug inspection in the United States,and analyzes the shortcomings in the implementation of risk-based drug registration inspection in China through comparison.Some specific suggestions are put forward to promote more scientific and standardized risk-based drug registration inspection in our country.
Keywords：Risk-basedDrug inspectionRegistrationComparison and analysis
Publication Date：2024-01-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 93-98 )