Exploration and analysis of common problems and countermeasures in the change of production process of listed Chinese traditional medicine
MA Lingling
ZHAO Lanting
LIU Hui
SUN Mingwei
LU Xueming
WANG Chunfang
YANG Yingying
YIN Ningning
WU Haijun
Abstract：Objective To understand the current status and urgent issues to be solved in the change of production process of listed traditional Chinese medicine,providing references for scientific and standardized research on the change of listed traditional Chinese medicine conducted by holders and for the technical review and supervision by regulatory authori-ties.Methods By sorting out and summarizing the difficult problems in the process of changing the production process of listed traditional Chinese medicine in Shandong Province,analyzing the possible risks and problems,and in view of the sci-entific and standardized Chinese medicine production process changes and reasonable to solve the problem,discusses the ef-fective control of risks and advice were put forward.Results The results of this study indicate that holders of drug market-ing authorization have problems such as insufficient verification of change research,unreasonable classification of changes,and deficiencies in research data during the process of traditional Chinese medicine production process changes.Conclusion This study puts forward reasonable suggestions from strengthening the management of TCM production process change.The holder of drug marketing authorization should fully fulfill its main responsibilities,strengthen the construction of drug quality management system,leverage advanced production technology,and continuously improve the level of product quality control,reasonably carry out changes in the production process of traditional Chinese medicine preparations;Drug regulatory depart-ments can strengthen regulatory services by adopting publicity and implementation,training,case sharing and other ways to improve the business ability of regulatory personnel.
Keywords：Listed traditional Chinese medicineChange of production processChange managementProblem analysisComments and suggestions
Publication Date：2025-03-30
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 302-306,312 )