Abstract: Objective To analyze the current regulation of post-approval changes to pharmaceutical products both at home and abroad so as to provide references for the research on and regulation of post-approval changes in China. Methods The systems for post-approval changes to drugs in the United States, Europe, and China and the provisions of ICH Q12 were compared and analyzed. Domestic regulatory requirements and industrial practices were taken into consideration. Results China's framework for regulation of post-approval changes was basically full-fledged. However，due to the complexity of variations, multiple regulatory bodies in China, and disparities in the development of the pharmaceutical industry between provinces, there was still room for improvement in this field. Conclusion Regulators of drugs and manufacturers should collaborate closely to keep upgrading the management system for post-marketing changes by strengthening the lifecycle mana-gement of drugs, adopting the same standards, and enhancing the management capabilities of marketing authorization holders.

Key words: Post-Approval Changes to Pharmaceutical Products, ICH Q12, Risk Supervision, Lifecycle Management of Drugs, Marketing Authorization Holders