I've been with Syngenta just Over 2 years now and Instrata Elite has been with us a little longer. This is the first addition to a product label I've encountered since I joined Syngenta and I had a number of questions for our brilliant regulatory team which I thought I'd share -
Picture the scene we're all sat in our home offices (spare bedroom, dining room table and a deck chair - that's right our offices are still pretty much shut) talking to our computers........................
Why wasn’t it included on the original label?
It was not a key disease for the success of the project at the time. The Research & Development resource would have been focused on Microdochium, dollar spot and Anthracnose.
We did try to achieve a Red Thread recommendation for the original registration but we didn't present enough Red Thread data for it to be approved.
How much work goes into getting it on the new label?
We have to prepare a new dossier, however a lot of that work has been done in the original application so most of the work has already been done. The new bit is the new efficacy data gathered in the new trials.
How many trials do we have to do?
Red thread is considered a major disease by Chemical Regulation Division (CRD) so a minimum of 6 supportive trials are required over a minimum of 2 years. These trials must all be from the maritime Climatic zone for the UK. In this case, we already had some data from the original submission.
Who do we need to convince?
In this case it was a national submission for a label extension to the UK authority – so all submitted to the CRD.
In theory, they would evaluate it to the same rules as any other EU country.
How long does it take to get things added to label?
1 year, best case, assuming no delays nor questions but generally it takes longer.
Could you have used it on red thread without red thread on label?
No, as the labels says… USING THIS PRODUCT IN A MANNER THAT IS INCONSISTENT WITH THE LABEL MAY BE AN OFFENCE.
Using it in anyway not stated on the label maybe an offence - that includes:
- Different crops
- Different doses / application rates
- Different diseases / pests
- Different water volumes
It takes a lot of work to get the registrations, The labels are througher for a reason.
How much of your time would this take?
A considerable amount, the trial protocols, trial management, data consolidation and writing a Dossier take up a considerable portion of our time. This particular one was submitted in December 2018, That gives you an idea of the work and time scales involved.
It's great to see that once we have a full registration the work on these products doesn't stop. Post registration, we continue to invest in additional trial work and where appropriate additions to the label.