The letter sent by BIVDA on behalf of members has been escalated with UKHSA separately to the team conducting the CTDA process. We have spoken directly to the procurement and market engagement teams, and our concerns have been acknowledged, but with no indication of a resolution at this stage. We have made it very clear that we expect a formal response quickly.
We have a meeting next week with the CTDA team, as we proposed at our last meeting held on Tuesday to hold a webinar for members to go through the common errors and issues that the CTDA evaluation team are facing.
Whilst there are problems with the implementation overall, and the legislation poses its own problems, ultimately any assistance that BIVDA can provide the CTDA team, and members by supporting the practical submissions will be valuable.
Any supplier relying on TVG data is expected to have this provided in time for the deadline at the end of December. If you do not have a confirmation of receipt for the request, then you should re-send with the original request to the same address with your application number clearly labelled.
Please NOTE for Lateral Flow devices, the Phase 3 PORTON DOWN evaluation data will not meet the validation requirements, so suppliers must not rely on this as it won’t be provided as it insufficient.
They have also emphasised very strongly, that comparator assays must be CE marked, and if a CE marked assay was not available at the time, their expectation is that suppliers would have commenced the studies when the Coronavirus Test Device Regulation criteria was published in June.
Ashleigh robustly pointed out that the time limit for this would have been extremely difficult for suppliers if they had have commenced this in June but will be impossible for any supplier attempting this from the deadline date in August.
We asked if it were possible to have details of issues with applications, and as expected – they cannot provide this for commercial confidentiality reasons, but they did say that suppliers could forward BIVDA their correspondence for us to look at and they would be happy to discuss in appropriate circumstances, so if you have any applications queries/ outstanding issues – please share with us in confidence and we will help to support you and push through where we can.
We are continually liaising with the CTDA team, and where members have asked questions, or sought our support we will be getting back to you as soon as answers are provided.
Please contact Helen for any further information.
