刍议FDA米多君片审评审批历程及对我国药品监管的启示  

Discussion on review and approval process of FDA Midodrine Hydrochloride Tablets and its implications for China's drug regulatory

作　　者：李新英 宗欣[2] 张凤琴 董江萍[4] LI Xinying;ZONG Xin;ZHANG Fengqin;DONG Jiangping(College of Business Administration of Shenyang Pharmaceutical University,Shenyang 110016,China;China Data Center of China Food and Drug Administration,Beijing 100053,China;Center for Drug Evaluation of China Food and Drug Administration,Beijing 100022,China;Center for Food and Drug Inspection of China Food and Drug Administration,Beijing 100044,China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]国家食品药品监督管理总局信息中心,北京100053 [3]国家食品药品监督管理总局药品审评中心,北京100022 [4]国家食品药品监督管理总局食品药品审核查验中心,北京100044

出　　处：《药物评价研究》2018年第9期1577-1580,共4页Drug Evaluation Research

摘　　要：美国食品药品管理局(FDA)在聚焦临床需求的监管理念和策略的实践中,不断调整修正监管在法规和措施上不适应,对我国完善药品监管制度有借鉴价值。采用文献研究法,通过查找相关文献以及FDA网站发布的一些信息和数据以及专家访谈,研究分析产品的临床治疗特点和审评审批历程,并就其存在的现象进行思考,旨在分析心血管疾病治疗药物盐酸米多君片在美国获得加快审评审批、上市、撤市、再次批准上市等全过程,探讨FDA聚焦临床需求的风险-获益平衡的药品监管理念及相关策略和措施,以期对我国药品审评审批的理念调整和监管制度的完善提供借鉴。In the practice of monitoring concepts and strategies that focus on clinical needs, the FDA constantly adjusts and modifies regulatory oversight in terms of regulations and measures, which has the value for the reference to improve drug regulatory system in China such as review and approval. The literature research method was adopted in this article. The characteristics of clinical treatment of the products were analyzed based on the search for relevant literatures and some information, data published by the FDA website, and interviews with experts to review the evaluation process and reflect on its existing phenomena. The purpose of this article was to comb, analyze, and research the whole process of accelerating the approval, review, listing, withdrawal, and re-approval of the market for the treatment of cardio-vascular diseases such as midodrine hydrochloride in the United States, and to discuss the risk of the FDA focusing on clinical risk-benefit balanced pharmaceutical supervision concepts and related strategies and measures, with a view to providing reference for the adjustment of the concept of China＇s drug review approval and the improvement of the regulatory system.

关 键 词：药品审评审批 盐酸米多君 撤市 药品监管 

分 类 号：R954[医药卫生—药学]