Abstract: Objective To analyze the data from China's Adverse Drug Reaction (ADR) monitoring, explore developments, and propose strategies for building a more efficient and precise pharmacovigilance system. Methods The data from the 2020-2024 annual reports released by the National Adverse Drug Reaction Monitoring Center of China was reviewed and analyzed. Results Substantial progress was made in China's ADR monitoring, such as the huge increases in the number of reports and continuous optimization of the monitoring network. However, challenges persisted, including inadequate participation of reporting entities (especially MAH), insufficient risk monitoring for key populations (e.g., children and the elderly), incomplete safety assessments of high-risk drugs (e.g., novel antitumor agents and biologics), and slow progress in information technology and intelligent capabilities. Conclusion To address these challenges and enhance drug safety surveillance, it is recommended that the regulatory framework for ADR monitoring be updated, responsibilities and abilities for reporting be upgraded in such key entities as MAH, medication safety for vulnerable groups (children/elderly) be prioritized, lifecycle supervision and signal detection for high-risk drugs be enhanced, IT and AI technologies be integrated in monitoring, and literacy about rational medication and awareness of pharmacovigilance be improved.

Key words: Adverse Drug Reaction, Pharmacovigilance System, High-Risk Drugs, Digital System Building, Monitoring Network, Annual Reports