Abstract: ObjectiveAccording to the introduction of EU pharmacovigilance system and its implementation progress, suggestions were put forward to provide the example and reference for perfecting and developing pharmacovigilance system of China. MethodsLiterature study was used to analyze the foreign and domestic materials. ResultsWithin the EU pharmacovigilance system, there are complete and standard legal documents, clear obligation, simplified and reasonable procedures and public information to effectively guarantee the safety of drugs throughout the life cycle. ConclusionWe should learn from EU pharmacovigilance system to improve our ability to monitor drug safety.

Key words: EU, EMA, pharmacovigilance system, pharmacovigilance legislation