OBJECTIVES: As a part of safety regulation, ADR monitoring plays an important role in the post-market surveillance. The purpose of this study was to evaluate China’s ADR monitoring system and to provide insights for improving the system. METHODS: ADR data (2008-2012) were collected from reviewing the National ADR Information Bulletin, Pharmacovigilance Express, Annual Report of National ADR Monitoring, and an on-site data extraction from the National Center for ADR Monitoring. Effectiveness assessment was made based on both internal (e.g., quality of ADR reports, information processing efficiency, and risk control actions) and external indicators (e.g., ADR reporting rate and serious ADR control). RESULTS: During 2008 to 2012, the number of ADR reports increased from 602,000 to 1,200,000, of which serious ADR reports accounted for 13.3% to 20.0%. Reports from medical institutions declined from 85.7% in 2008 to 74.8% in 2012, while reports from pharmaceutical manufacturers and sellers increased from 10.4% to 24.4%. For the scope of monitoring, 34 provincial and 333 municipal ADR monitoring centers had established by 2012. The new ADR Monitoring Network System began running in 2011 and the number of network users rapidly increased from 34,000 to 150,000. For information processing efficiency, the average time lag between ADR occurrence and reporting was 23.6 days for overall and 20 days for serious cases. Regarding risk control actions, 33 National ADR Information Bulletin and 38 Pharmacovigilance Express were issued during 2009 to 2012. Sales restricting or suspending were executed 4 times, along with 27 drug label modifications and 6 drug recalls. CONCLUSIONS: China’s ADR monitoring system have achieved a progress in recent years and functioned well to some extent. Efforts are needed to remove the barriers in ADR reporting and enhance risk control actions. More research on evaluating ADR monitoring system is also warranted.