关键词: 药物警戒体系, 欧盟, 药品不良反应监测与报告, 监管, 建议, 启示

Abstract: Objective To draw experience from pharmacovigilance system construction in EU, provide reference for pharmacovigilance system in China. Methods Introduce the organization structure and pharmacovigilance processes of EU pharmacovigilance system, compare the differences in regulations, directives and pharmacovigilance processes between China and EU, and provide advice on the improvement of drug adverse reaction monitoring and reporting in China. Results and Conclusion There are many differences between the drug adverse reaction monitoring and reporting system in China and EU pharmacovigilance system, such as the basement of regulation, the system design and the working mechanism. It is helpful for us to reform the drug adverse reaction monitoring and reporting in China borrowing the EU pharmacovigilance and enhance the interaction between drug administration and drug safety monitoring after drug approval. It would encourage the pharmaceutical enterprises taking responsibility of drug safety, promote the policy coordination of drug regulation, and improve the administration efficiency.

Key words: pharmacovigilance system, EU, drug adverse reaction monitoring and reporting, administration, advice, implication