To put forward some suggestions on post-approval change management of drugs based on ICH Q12 for our country.

The EU and China regulatory frameworks and classification requirements of post-approval CMC changes of chemical drugs under ICH Q12 were studied, and our deficiencies on management of post-approval drug changes were analyzed.

The EU has issued the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management-Scientific Guideline, which establishes a globally recognized framework. This guideline demonstrates mature lifecycle management concepts, comprehensive management tools, clear change procedures, and efficient review communications. It enables enterprises to better understand critical elements of products and manufacturing processes through ICH Q12 tools, facilitates more efficient implementation of post-approval CMC changes, reduces corporate change costs, and conserves regulatory review resources.

China can dram on the mature experience of EU regulatory authorities to optimize its post-approval CMC change management system in accordance with ICH Q12. These measures would enhance the efficiency and scientific rigorousness of pharmaceutical post-approval CMC change management in China while alleviating burdens on marketing authorization holders (MAHs) and regulatory authorities.