Analysis and research on common problems in the registration and inspection of chemical drugs produced overseas
LI Wen-long
WANG Xue-lei
TAN Li-yuan
WEI Jing-jing
MEN Ying-xuan
WU Zhao-yang
SHI Jia
WANG Yan
ZHANG Qing-sheng
Abstract：The registration testing is a prerequisite for the marketing of drugs.This paper aims to continuously promote the applicants for drug registration to provide scientific and standardized reporting information and samples,thereby assisting the inspection agency to accurately assess the sample quality and to improve the quality and efficiency of the registration testing process.By reviewing the relevant provisions in registration and inspection in"Provisions for Drug Registration"and"Drug Registration and Inspection Work Procedures and Technical Requirements Specification(for Trial Implementation)",this study examines the registration and inspection data review for overseas produced chemical drugs,summarizes the common issues in the registration and inspection combined with practical experience,analyzes their underlying causes,and puts forward strategies and solutions.The study found that many registration applicants lack a comprehensive understanding of the registration and inspection procedures related to overseas produced chemical drugs.Issues identified include technical information,quality standards,samples and reference substances,etc.There are problems such as inaccurate information,mismatch of information,inconsistency between sample packaging materials and declarations,as well as insufficient residual validity period.It is recommended that regulatory agencies enhance training and guidance,accelerate the revision of policy documents,breakthrough the review and inspection of the communication mechanism,enable the applicant to in-depth study and understand the system documents,emphasize on the consistency issues,fully prepared for the pre-test and method development,in order to improve the quality of the declaration information,and efficiently complete the registration and testing.
Keywords：chemical drugs produced overseasimported drugsregistration testingsamplesreference substancesapplication documentscommon issuesregulatory science
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：5( 1035-1039 )