Abstract: Objective According to the introduction of new pharmacovigilance legislation in EU, suggestions were put forward to provide the example and reference for perfecting and developing adverse drug reation reporting and monitoring system of China. Methods Literature study was used to analyze the foreign and domestic materials. Results New pharmacovigilance legislation in EU focuses on collection of key information on medicines, better analysis and understanding of data and information, regulatory action to safeguard public health and communication with stakeholders. Conclusion We should learn from the new EU pharmacovigilance law to improve capabilities of adverse drug reaction reporting and monitoring.

Key words: EU, EMA, pharmacovigilance legislation