粤公网安备 44011302004783号 江苏：推进优化药品补充申请审评审批程序改革试点
8月28日讯，江苏省政府办公厅印发《关于全面推进药品医疗器械监管深层次改革促进医药产业高质量发展若干政策措施的通知》。《通知》提到，推进优化药品补充申请审评审批程序改革试点，推动需要核查检验的补充申请审评时限由200个工作日缩短为60个工作日。推进生物制品分段生产改革试点，探索跨境分段生产监管工作。争取优化创新药临床试验审评审批试点，推动审评审批时限由60个工作日缩短为30个工作日。争取高水平医疗机构自行研制使用国内尚无同品种上市的诊断试剂试点。争取仿制药立卷审查试点，支持首仿品种加快注册上市，提升仿制药质量水平。
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