阶段关卡模式在简略新药申请药品研发中的应用精要.docVIP

摘 要 研究目的：本文以美国简略新药申请药品研发为例希望通过研究梳理并分析企业在研发过程中的管理方式、流程和考虑因素，帮助企业高层管理者和研发人员在项目实施过程中更好的进行决策，同时通过对企业在研发过程中的决策考虑的详细描述为监管机构在监管要求的制定提供参考。 研究方法：通过文献搜集和总结分析建立初步的项目组合管理和仿制药研发阶段关卡模型，归纳出研发管理各阶段、主要关卡的考虑因素、标准，并通过访谈的方式对模型内容进行确认和改进。从文献和访谈等获取到的信息均被用于阶段关卡模型内容建设。 研究结果：通过对项目组合管理和仿制药研发项目管理阶段关卡模型的论述为企业在研发过程中“做正确的事”和“正确的做事”两个问题提供借鉴，企业可以此为基础建立适用于本企业的流程和检查要点，更好的进行决策从而提升研发能力，监管机构可通过对研发过程的理解提高其监管政策和要求制定的针对性从而提升监管效率。 关键词：组合管理；项目管理；研发；仿制药；阶段关卡模型 Stage-Gate Process for the Development of Abbreviated New Drug Application Objectives: This thesis hopes to unscramble and analysis the management practices, process and considerations of the development of the Abbreviated New Drug Application to help the enterprise top managers and the researchers make better decisions, at the same time provide a reference for the agencies’ regulatory requirements development by the comprehensive representation of company’s decision-making considerations in the RD process. Methods: Through literature search and analysis, the preliminary stage-gate model for project portfolio management and generic drug development was generated, including the content of each stage, gate considerations, criteria, and the model were presented to subsequent interviewees and iteratively revised and improved. Information available from the literature and interviews was used to build the body of model. Results: The stage-gate model for project portfolio management and generic drug development provides a reference for company to tackle with the issues of “do the right thing” and “dong things right”. Based on this model, company can build suitable process and check points to enhance its research and development ability, make better decisions. Regulators also can benefit from the model by understanding the research and development process to improve its regulation policy and requirement efficiency. Key words: Project portfolio management, Project management, Research and development, Generic drugs, ANDA, Stage gate model 目　录 第 1 章 引言 1 1