2012年11月22日,国家食品药品监督管理局注册司发布了有关仿制药质量一致性评价的征求意见稿。2016年3月5日,《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》(以下简称国8号文)正式拉开仿制药一致性评价大幕。由此不难看出,此次仿制药一致性评价绝非行业决策,而是国家层面的决策。国8号文对开展仿制药一致性 On November 22, 2012, the Registrar of the State Food and Drug Administration released a draft for comment on the consistency of generic drug quality. On March 5, 2016, the Opinions of the General Office of the State Council on Evaluating the Consistency of the Quality and Efficacy of Generic Drugs (hereinafter referred to as the State 8 Document) formally opened the curtain on the consistency assessment of generic drugs. It is not difficult to see that the generic evaluation of generic drugs is not industry decision-making, but the national level decision-making. State 8th article on the compliance of generic drugs