生物技术药物安全风险监管制度研究  

A Research on the Legal Systems of Biotech Drug Safety Regulations

作　　者：程诗媛 Cheng Shiyuan

机构地区：[1]华中科技大学法学院

出　　处：《私法》2020年第2期-,共24页Private Law Review

摘　　要：在风险社会背景之下,伴随着生物技术药物产业的快速发展,生物技术药物安全风险也不断涌现。生物技术药物安全风险具有隐蔽性、不可逆性和泛地域性等特征,并且可以根据不同标准对其加以分类。本文在考察我国生物技术药物安全风险的核心监管制度,即药品上市许可持有人制度和药物警戒制度的现状和实践基础之上,从比较法的视角对欧盟生物技术药物安全风险监管制度加以考察梳理,并在此基础上提出完善我国生物技术药物安全风险监管制度的对策建议。In the context of risk society,with the rapid development of biotech drug industry,the safety risks of biotech drugs are also emerging.The safety risks of biotech drugs have the characteristics of concealment,irreversibility and are pan regional,and also can be classified according to different standards.Based on the investigation of the current situation and practice of main regulatory systems for the safety risks of biotech drugs in China(the marketing authorization holder system and the pharmacovigilance system),this paper reviews the EU biotechnology drug safety risk regular system from the perspective of comparative law,and on this basis,puts forward the countermeasures to improve the regulatory system of biotech drug safety in China.

关 键 词：生物技术药物 风险 监管 药品上市许可持有人 药物警戒 

分 类 号：D922.16[政治法律—宪法学与行政法学]