Abstract: By introducing the revision of European Union(EU) Pharmocovigilance regulation, it helped to know the structure of EU Pharmacovigilance system better. And it also clearly showed the contents of the system, such as Pharmacovigilance Systems and their Quality Systems, Pharmacovigilance System Master File, Pharmacovigilance Inspections, Risk Management Systems. It provided the example and reference for perfecting and developing Adverse Drug Reaction Reporting and Monitoring System of China.

Key words: European Union, new regulation, pharmacovigilance, system