The TGA has not requested evidence (analytical or clinical) forBA/4,BA/5, and BA.2.75 sub-variants under s41JA. Please accept thisemail as a reminder that the manufacturer should be proactivelyundertaking studies, and when the TGA sends an official requestthere should be no delay in providing evidence. Please keep thisadvice in mind for each time a new variant becomes predominant.
TGA没有要求提供s41JA下BA/4、BA/5和BA.2.75亚变异体的证据(分析或临床)。请接受此电子邮件,提醒制造商应积极开展研究,当TGA发出正式请求时,应立即提供证据。每次新的变体占主导地位时,请记住这一建议。
If the manufacturer has completed these studies prior to theTGA’s formal request under section 41JA of the Therapeutic GoodsAct (1989), please provide them to the TGA as soon as possible.
如果制造商在TGA根据《治疗品法案》(1989)第41JA节提出正式请求之前完成了这些研究,请尽快将其提供给TGA。
IVDEAR可承接新冠前瞻性实验,BA.4,BA.5,BA.2.75变异株临床试验研究!