欧盟上市许可人制度下药品安全相关责任主体法律责任分析及其启示

摘要

借鉴欧盟先进经验，为我国构建上市许可人制度下药品安全法律责任体系提供参考。该文采用法条分析法、制度分析法、文献研究法，对欧盟上市许可人制度下药品安全责任主体的职责义务和法律责任进行梳理和分析。欧盟MAH制度下的药品安全职责划分明确，责任易追究，我国应借鉴欧盟的先进经验，不断完善药品安全法律责任体系。%Systematically summarize the obligation and corresponding legal responsibility of each subject of liability under European Union MAH system. Summarize and analyze obligation and legal responsibility of EU MAH system. EU divides drug safety responsibility specifically and explicitly. Our state should fully draw lessons from advanced experience of EU.