我国新药审评项目管理影响因素研究

On Influencing Factors of New Drug Evaluation Project Management in China

目的:提取和筛选出我国新药审评项目管理的影响因素,为我国药品监管部门建立新药审评项目管理模式提供参考。方法:运用项目管理理论、文献研究法,提取我国新药审评项目管理影响因素,并通过问卷调查法和因子分析法建立我国新药审评项目管理影响因素指标体系,并对指标体系重要性进行评估和权重分析。结果:在二级指标上的权重排序是药品审评项目计划管理>审评时限管理>药品审评项目团队组织结构>项目管理人的能力>药品审评项目过程管理>项目管理人的职权>药品审评质量管理。在三级指标上,细化审评流程、选择合适的项目管理人和建立完善的药品审评质量评价体系是影响最大的因素。结论:在审评项目启动前,首先,要细化审评流程,制定审评计划,审评计划的制定是明确审评目标和在规定时限完成的前提;其次,选择合适的项目管理人,保证沟通和信息的高效流通;最后,进一步完善药品审评质量管理,保证审评质量和效率。

Objective:To establish the management mode of new drug review project management for the medical products authorities in China by the analysis of the influencing factors of China’s new drug review project management.Methods:The key influencing factors of the project management of drug review in China were obtained by using project management theory and literature retrieval method.The index system of influence factors of drug review project management was established by questionnaire survey and factor analysis method,and was applied to the evaluation of the index system importance and weight analysis.Results:The weighting sequences on the secondary indicators were drug review project plan management>drug review project time limit management>drug review project organization structure>capacity of the project manager>drug review project process management>the authority of the project manager>drugs review quality management.On the third-level indicators,detailed review process,appropriate project managers and establishment of a sound drug evaluation quality system were the most influencing factors.Conclusion:Firstly,before the review project was launched,it was necessary to detail the review process and develop a review plan.The review plan was developed to clarify the objectives of the review and the prerequisites for completion within the specified time.Secondly,an appropriate project manager was selected to ensure efficient communication and information.Finally,the quality management of drug reviews was further improved to ensure review quality and efficiency.