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为优化药品和医疗器械审评审批流程,提高审评审批效率,日前,食品药品监管总局发布总局令31号《国家食品药品监督管理总局关于调整部分药品行政审批事项审批程序的决定》和总局令32号《国家食品药品监督管理总局关于调整部分医疗器械行政审批事项审批程序的决定》,对食品药品监管总局负责的临床试验审批事项、再注册和延续注册审批事项、注册变更审批事项等药品和医疗器械行政审批事项的审批程序进行调整。
In order to optimize the examination and approval process of pharmaceuticals and medical devices and improve the efficiency of examination and approval, a few days ago, the State Food and Drug Administration released Decree No. 31 of the State Administration of Food Safety and the Decision of the State Food and Drug Administration on Adjusting and Approving the Examination and Approval Procedures of Some Administrative Items of Pharmaceutical Administration and the Order of the General Administration No. 32 “Decision of the State Food and Drug Administration on Adjusting the Examination and Approval Procedures for Some Items of Administrative Examination and Approval for Medical Devices”, re-registration and renewal of examination and approval matters, registration of alteration examination and approval items, and other drugs and pharmaceuticals that are responsible for the clinical trial approval matters of the State Food and Drug Administration Medical devices administrative examination and approval issues to be adjusted.