美国药品橙皮书制度研究与我国建立橙皮书制度之必要性探讨

Analysis of Orange Book System in USA and Discussion of the Necessity of Establishing Orange Book System in China

目的:对美国橙皮书制度进行探讨,结合行业发展情况探讨我国建立橙皮书制度的必要性。方法:文献研究和专家咨询法。结果:对美国橙皮书制度从发展历程等8个方面进行介绍,围绕橙皮书制度的作用,从4个方面探讨建立我国橙皮书制度的必要性。结论:美国橙皮书制度是随着FDA对药品监管的不断进步而逐步丰富和完善的。从解决我国当下行业问题以及长远发展的角度来看,我国建立药品橙皮书制度十分必要。

Objective To analyze Orange Book system in USA and to discuss the necessity of establishingOrange Book system in China based on the development of China＇s pharmaceutical industry. Methods： Literatureresearch and expert consultation methods were used. Results： Eight aspects of the Orange Book system in theUSA including development history were introduced. The necessity of establishing Orange Book system in Chinawas discussed from four aspects of the role of the Orange Book system. Conclusion： The Orange Book system inUSA was gradually enriched and improved along with the continuous progress of FDA drug regulation. From theperspective of solving the current problems of industry and the long-term development, it is necessary to establishthe Orange Book system in China.