| 张彦彦,杨建红,武志昂.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[J].中国药事,2017,(10):1123-1130 |
| 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 |
| 投稿时间：2017-04-08 |
| DOI：10.16153/j.1002-7777.2017.10.005 |
| 中文关键词: 药品橙皮书 已批准药品信息 参比制剂 专利链接 治疗等效性代码 信息公开 |
| 英文关键词: Orange Book information of approved drugs reference preparation patent link therapeutic equivalence code information disclosure |
| 基金项目: |
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| 摘要点击次数: 1049 |
| 全文下载次数: 1230 |
| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: To analyze Orange Book system in USA and to discuss the necessity of establishing Orange Book system in China based on the development of China's pharmaceutical industry. Methods: Literature research and expert consultation methods were used. Results: Eight aspects of the Orange Book system in the USA including development history were introduced. The necessity of establishing Orange Book system in China was discussed from four aspects of the role of the Orange Book system. Conclusion: The Orange Book system in USA was gradually enriched and improved along with the continuous progress of FDA drug regulation. From the perspective of solving the current problems of industry and the long-term development, it is necessary to establish the Orange Book system in China. |
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