仿制药一致性评价作为当前和今后一段时期内医药行业和各级药品监管部门的重大任务之一,其实施进程必将给当前整个医药行业带来强烈的政策震荡,产生诸如医药制造领域里供给侧结构性改革的启动,国产药品质量大幅度提升,加速医药行业的产业结构调整,实现行业资源整合和转型升级以及增强医药产业国际竞争能力等影响,本文对此进行深入分析并提出相应的规制建议。 As one of the major tasks of the pharmaceutical industry and the pharmaceutical regulatory authorities at all levels, the implementation of generic drug consistency assessment will surely bring about a strong policy turmoil to the current pharmaceutical industry as a whole. The process of providing such drugs as pharmaceuticals The start of structural reform, the substantial improvement of the quality of domestic medicines, the acceleration of industrial restructuring in the pharmaceutical industry, the consolidation and transformation of industry resources, and the enhancement of the international competitiveness of the pharmaceutical industry. In this paper, we conduct in-depth analysis and propose corresponding regulations Suggest.