通过文献研究和专家咨询确定我国橙皮书制度构建的关键要素，针对关键要素及实施路径设计问卷并进行问卷调研，对我国橙皮书制度的"基本定位及作用、需要的法律支持、收录药品的基本原则、参比制剂的收录原则、药品标识、收载的药品信息、制度实施的组织机构及工作机制"等7个方面要素的调研结果进行分析，为提出我国橙皮书制度构建和实施路径研究建议提供支持。

Through the literature research and expert consultation to determine the key elements of the construction of Chinese Drug Orange Book System, for the key elements and the implementation path to design questionnaire and conduct questionnaire survey. Seven key elements of Chinese Drug Orange Book System were identified through the study, including the basic position and role, required legal support, the basic principles of drug collection, the principle of reference listed drug collection, drug identification, drug information, the organization, and working mechanism. The analysis of the results of the survey provides support for the proposal on the construction and implementation path of Chinese Drug Orange Book System.

国家药典委员会资助项目