Exploratory investigation on the dynamic management of reference listed drugs for chemical generic drugs
YANG Dong-sheng
FENG Yu-fei
LIU Nian
LIU Qian
ZHANG Guang-chao
NIU Jian-zhao
MA Ling-yun
Abstract：The application for chemical generic drugs(registration categories 3,4,5.2)and the re-evaluation of quality and efficacy consistency must utilize reference listed drugs listed in the directory published by the National Medical Products Administration.There are multiple sources of reference listed drug for generic drugs in our country,and quite a few of them are not listed in our country.For the reference listed drug adopted,the directory only provides limited information.While during the entire product life cycle of the reference listed drug,it is affected by various factors,and inevitably undergoes various changes,but the changes cannot be reflected in the directory in a timely manner.By investigating the information and database related to reference listed drug in China and abroad,the paper analyzes and classifies the existing problems,and puts forward the idea of constructing reference listed drug database,which can realize dynamic correlation between the Chinese reference listed drug directory and the information of the drug sources,improve the efficiency and quality of use,and make it better to provide services and support for the research and development,drug inspection,review and supervision of generic drugs.
Keywords：generic drugsreference listed drugsdynamic managementNational Medical Products Administrationtherapeutic equivalencegood manufacture practice
Publication Date：2025-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 1139-1147 )