英国启动对Moderna(MRNA.US)新冠疫苗mRNA-1273滚动审查程序
© Reuters. 英国启动对Moderna(MRNA.US)新冠疫苗mRNA-1273滚动审查程序
智通财经APP获悉， Moderna(MRNA.US)表示，英国药品和保健品监管局(MHRA)已启动对该公司新冠疫苗mRNA-1273的滚动审查程序。
Moderna已经提交mRNA-1273数据进行滚动申报，并有可能获得英国药品和保健品监管局的授权，前提是该疫苗符合MHRA要求的严格安全性、有效性和质量标准。一期中期分析显示，mRNA-1273在所有年龄组中普遍耐受良好，可诱导对新冠病毒产生快速而强的免疫应答。
据了解，滚动申报是指药企在申请新药上市许可时，可以先将送审资料的一部分完成后立刻提交，也就是依照类别将所完成的法规文件分批次递交进行药证核发申请，而不需要等到全部法规文件都完成之后才申请药证核发，此举可缩短新药的审查周期，一般可将时间表提前至少半年以上。
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