To be honest it makes sense that they have requested this information. I'm not happy about it, but from a butt-covering perspective, it makes sense.
The TGA has seen a new variant turn into a dominant one, within a matter of weeks, so it would be sensible to ask the company to outline a plan for how it will tackle all-new variants.
Given the acceptance of this plan, it will then also reduce the TGA's workload, by not having to constantly ask ADO to go back to them, every time a new variant pops its head up.
We can ask whether other companies are being held to the same standard, however, it probably makes us look better, if they are not.
Ann: TGA Registration Update, page-101
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