关键词: 人用药品, 药物警戒, 数据库

Abstract: Objective To intruduce the legal framework, working mechanism, responsibilities and access rights of various stakeholders of EudraVigilance, provide reference for pharmacovigilance database system in China. Methods Using literature analysis and comparative research methods, on the basis of understanding the EudraVigilance, examining the inadequacy of China's ADR System. Results EudraVigilance has clear statutory requirements for the responsibilities and authorities of various stakeholders, the function is perfect to realize the collection, management and analysis of EU drug safety information. Conclusion The adverse reaction monitoring system in China still needs to be strengthened in terms of legislation, access rights, data scope and information utilization.

Key words: medicines for human use, pharmacovigilance, database