摘要
Abstract
In recent years, the drug safety accidents, drug safety supervision management become very concerned about the public. It has been founded in 1998, the State Food and drug administration is a product of the institutional reform of the State Council, which solves the medical field the problem such as authority overlapping, and the use of administrative license, information disclosure and other means to regulate the drug safety, trying to achieve the policy objective-- "in supervision center, supervision, help, promoting the combination". However, it could also be seen that recently various of problems of drug safety and related cases come out, large law cases with big influence happens in succession. The comprehensive ef ect of drug regulators function positioning is not accurate,institutions set up unreasonable, the system design is not perfect, the decision-making mechanism is not scientific, the deep-seated institutional reasons causing problems. The paper is composed of six parts, including foreword and five main text chapters. The introduction part puts forward the research question. The second part reviews the regulation of Chinese drug safety and the historical evolution and restructuring. The third part compares the drug supervision mode in dif erent countries. The fourth part discusses many contradictions in the field of drug safety in China. The fifth part discusses the social causes of the problems of drug safety. The last to improve the oversight system for drugs, solve the problem of drug safety.关键词
药品监管/制度变迁/制度比较/监管体制Key words
Drugs monitoring/Institutional change/Institutional comparison/Supervision system
