美国、欧盟和我国实施ICH Q12管理工具的比较研究

A comparative study on the implementation of ICH Q12 management tools in the United States,the European Union and China

针对药品批准后CMC变更管理,ICH Q12提出了批准后CMC变更分类、既定条件、批准后变更管理方案、产品生命周期管理文件等管理工具。美国、欧盟和我国在实施这些管理工具上有不同的做法。借鉴和参考美国、欧盟的实施经验,对于优化我国的CMC变更管理具有重要意义。本文对转变监管部门对药品批准后CMC变更管理的理念、对变更进行分类管理、优化变更管理工具提出建议。

For post-approval CMC Changes,ICH Q12 proposed management tools such as categorization of post-approval CMC changes,ECs,PACMP,and PLCM documents.The United States,the European Union and China have different approaches in implementing these management tools.It is of great significance to learn from and refer to the implementation experience of the United States and the European Union for optimizing China’s post-approval CMC change management.We hope to change the supervision department’s concept of post-approval CMC change management,manage changes by category,and optimize change management tools.