the TGA is undertaking a post-market review of the ability ofCOVID-19 test kits to detect emerging variants. As such,the TGAroutinely requests for analytical and clinical performance data ofall Rapid Antigen Tests (RATs) included in the Australian
TGA正在对新冠肺炎检测试剂盒检测新出现变异的能力。因此,TGA定期要求澳大利亚试验中包括的所有快速抗原试验(大鼠)的分析和临床性能数据。
Register of Therapeutic Goods (ARTG) for the predominantvariants such as Delta and Omicron.
主要变体(如Delta和Omicron)的治疗品登记册(ARTG)。
随着新的变异株成为主导,各企业就要准备新的临床,以便第yi时间提交机构审核!