关键词: 中药制剂, 生产场地变更, 变更管理, 问题分析, 意见建议

Abstract: Drug change management is an important way to achieve continuous improvement of drug quality， and it is also an important part of drug regulation.The implementation of classified management for changes in marketed drugs is a continuous optimization of drug regulatory methods and concepts， and a major breakthrough in drug change management.Based on the management of changes in the production site of marketed traditional Chinese medicine preparations， this study reviewed the history of production site change management， analyzed the current situation of changes in the production site of traditional Chinese medicine preparations in Shandong Province since the implementation of the new version of the “Drug Registration Management Measures”， as well as common problems in the review process of production site changes， and clarified the contents that should be focused on in the process of production site changes.Finally， several considerations are proposed from the aspects of incomplete process parameters， low quality standards for some varieties， and increased risks in production process control of traditional Chinese medicine preparations.It is proposed to continue to improve the legal and regulatory system for change management， increase publicity and training， and strengthen the management concept of change for drug marketing license holders， in order to provide reference and technical support for the scientific supervision of changes in the production site of marketed traditional Chinese medicine preparations.
 

Key words: Traditional Chinese medicine preparation, Production site change, Change management, Problem analysis, Comments and suggestions