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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 literature review and expert consultation, we determine the key elements of the construction of the Orange Book system in our country, design the questionnaire based on the key elements and the implementation path, and make a survey on the basic orientation and function of the Orange Book system in China and the legal support we need The basic principles of medicine, the principle of collection of reference preparations, drug identification, contained in the drug information, the institutional implementation of the system and working mechanism "and other seven aspects of the survey results to analyze the proposed orange book system in China And implementation of path research recommendations.