中国药房2017，Vol.28Issue(4)：437-441,5.DOI:10.6039/j.issn.1001-0408.2017.04.02
美国药品安全监管机制研究及启示
Research and Enlightenment on the Drug Safety Supervision Mechanisms in USA
摘要
Abstract
OBJECTIVE:To provide references for perfecting the drug safety supervision mechanisms in China. METHODS:Based on the theory of“market failure”“contract failure”and“government failure”,representative drug safety supervision mecha-nisms were selected from USA for analysis and evaluation. RESULTS & CONCLUSIONS:USA has made some achievements in the implementation and application of drug safety supervision mechanisms. The representative drug safety supervision mechanisms included prescription drug applicant payment mechanism,drug safety information communication mechanism,punishment and in-centive mechanism, public-private partnership mechanism, passive monitoring and active monitoring combination mechanism. These mechanisms relieved“government failure”of FDA,and solved the problems of“market failure”and“contract failure”to cer-tain extent. In China,drug safety supervision mechanisms should be perfected from refining the legal guarantee,mobilizing exter-nal forces completely,absorbing and applying modern information technology,focusing on both prevention and disposal,paying at-tention to the coordination of different mechanism,striving for open procedure and transparent result.关键词
药品安全/监管机制/美国/研究/启示Key words
Drug safety/Supervision mechanism/USA/Study/Enlightenment分类
医药卫生引用本文复制引用
杨莉,田丽娟,罗刚..美国药品安全监管机制研究及启示[J].中国药房,2017,28(4):437-441,5.基金项目
国家社会科学基金资助项目（No.13CFX086）；辽宁省教育厅科学研究一般项目（No.W2014119）；沈阳药科大学中青年教师事业发展支持计划 （）
