通過文獻(xiàn)研究和專家咨詢確定我國橙皮書制度構(gòu)建的關(guān)鍵要素，針對關(guān)鍵要素及實(shí)施路徑設(shè)計問卷并進(jìn)行問卷調(diào)研，對我國橙皮書制度的"基本定位及作用、需要的法律支持、收錄藥品的基本原則、參比制劑的收錄原則、藥品標(biāo)識、收載的藥品信息、制度實(shí)施的組織機(jī)構(gòu)及工作機(jī)制"等7個方面要素的調(diào)研結(jié)果進(jìn)行分析，為提出我國橙皮書制度構(gòu)建和實(shí)施路徑研究建議提供支持。

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.

國家藥典委員會資助項(xiàng)目