TGA对新冠变异株BA.4/BA.5/BA.2.75临床试验的要求是什么？

Since the emergence of Omicron BA/4, BA/5, and BA.2.75 sub-variants, some sponsors have communicated with the TGA about the manufacturer’s ongoing monitoring and proactive testing of new variants as they appear.

自Omicron BA/4、BA/5和BA.2.75亚型变体出现以来，一些赞助商已与TGA制造商对新变体的持续监控和主动测试。

Guidance on studies undertaken

研究指导

Manufacturers are responsible for monitoring the performance of their device(s), to ensure there is no loss of performance and no increased risk of false negative results with new variants, as part of their PostMarket Monitoring and Quality Management Processes.

作为上市后监测和质量管理流程的一部分，制造商负责监测其设备的性能，以确保没有性能损失，也没有增加新变体出现假阴性结果的风险。

 For clinical studies, it is recommended that samples (fresh specimens) are collected while the current variants are prevalent in the community and easy to acquire.

·对于临床研究，建议在当前变异在社区中普遍且易于获取的情况下收集样本（新鲜样本）。

IVDEAR可承接BA.4,BA.5,BA.2.75新冠变异株临床试验