关键词: font-size:medium, ">药品批准后CMC变更；ICH Q12；管理理念；管理工具；比较

Abstract: Post-approval CMC change is an important way to achieve continuous improvement of drug quality and is an important part of drug lifecycle management. Implementing scientific supervision of post-approval CMC changes is one of the important tasks of drug regulatory departments in various countries and regions. In this regard， ICH Q12 “Techinical And Regulatory Considerations For Pharmaceutical Product Lifecycle Management” proposes advanced management concepts and effective management tools. By establishing a systematic approach to optimize change control and reduce potential quality risks after changes， it is possible to manage post-approved CMC changes in a more predictable and effective manner throughout the product lifecycle. The management of post-approval CMC changes in China is mainly based on the principle of risk management， and the current laws and regulations are relatively complete， aiming to play the main responsibilities of drug marketing authorization holder (MAH). Compared with the requirements of ICH Q12 on post-approval CMC changes， CMC change management concept in China is not advanced enough， the management tools are insufficient， the change procedures are not perfect， and the communication between evaluators and inspectors is not smooth enough. In the implementation process of post-approval CMC change management in China， there is a greater emphasis on risk management， and the speed and convenience of CMC changes are not sufficient. It is necessary to learn from the management concepts and management tools of ICH Q12，combined with China′s actual situation， and take effective measures to optimize the management of post-approval CMC changes in China. On the basis of sorting out the relevant regulations and classification requirements for a post-approval CMC change in China, this study analyzes the problems in current CMC change management. Through a comparison between China and ICH Q12 on post-approval CMC change, it proposes to draw on the ICH Q12 management concept and management tools, optimize the goals, tasks, and concepts of post-approval CMC change management in China, and carry out classification management， step by step implementation and other strategies based on the actual situation of Chinese pharmaceutical enterprises.

Key words: font-size:medium, ">Post-approval CMC changes； ICH Q12； Management concepts； Management tools； Comparison