CTDA backlog2 Jan 2022 08:58
No backlog, my arse:
GDR
The next milestone is approval by the Department of Health and Social Care, however, no assured timeline is provided on how long the review under CTDA regulations will take, given a current backlog in their reviews.
Ncyt
Novacyt submitted 11 products for review on time to meet the original CTDA submission deadline of 1 September 2021. To date, Novacyt's Primerdesign Ltd PROmate® COVID-19 test has been named on the temporary protocol (this encompasses both the PROmate® 1 Gene q16 and q32 products). The CTDA has not yet communicated the status of any of the remaining nine products.
Avct
Avacta submitted, ahead of the 1 September 2021 deadline, all the information required for its AffiDX test to be validated under these regulations by the UK Health Security Agency, and the Company has paid the required fee. The Company awaits further notification from the UK Health Security Agency when it completes its review of the information supplied for the AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test.
And
We are progressing with our application to the CTDA in order to put the AffiDx product on the market in the UK