浅析美国药品质量规制对我国的启示

目的比较中美药品质量规制制度的差异,探讨美国药品质量规制中值得我国借鉴之处。方法运用法学、行政管理学、社会学的研究思路,比较两国药品质量规制制度,重点分析制度的合理性和运行效率。结果与结论药品质量规制的制度设计、机构设置和实施过程应具备科学性,我国在借鉴国外设计思路的同时,应更加重视制度的实施过程,确保规制效果。

Enlightenment of US Drug Regulation System for Our Nation

Objective To investigate the useful reference of the US Drug Regulation System for our nation by comparing the pharmaceutical regulation systems of US and China. Methods This paper focused on analyzing the rationality and operating efficiency of the pharmaceutical regulation system, comparing the drug regulation systems of the two nations using such research approaches of sciences of law, administration and sociology. Results and Conclusion The result shows the regulation system design, institution setting and implementation process should acquire scientificness. When referring to the foreign design ideas, we should emphasize more on the implementation process to ensure the efficacy of the system.