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为加快具有临床价值的新药和临床急需仿制药的研发上市,解决药品注册申请积压,国家食品药品监管总局26日发布意见,明确具有明显临床价值的创新药,临床急需、市场短缺的药品将优先审评审批。根据意见,此次纳入优先审评审批的药品共17种,包括具有明显临床价值、未在中国境内外上市销售的创新药和转移到中国境内生产的创新药注册申请;防治艾滋病、肺结核、病毒性肝炎等疾
To speed up clinical trials of new drugs and clinical research and development of much-needed generic drugs to solve the backlog of drug registration applications, the State Food and Drug Administration announced on the 26th, a clear clinical value of innovative drugs, clinically urgent, the market shortage of drugs will be given priority Review and approval. According to the opinions, there are 17 kinds of drugs that have been included in the priority review and approval process, including innovative drugs with obvious clinical value, not yet marketed in the PRC and overseas markets, and innovative drug applications transferred to China; prevention and control of AIDS, tuberculosis and viruses Hepatitis and other diseases