[关键词]
[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。
[Key word]
[Abstract]
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.
[中图分类号]
[基金项目]