Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Incorporation in Ireland is a hedge against no-deal Brexit issues relating to additional testing and packaging requirements for the importation of pharmaceuticals from non-EU countries. For example, the QP responsible for batch release has to be in an EU member state, packaging will need to carry new registration numbers.
More or less correct. It's an "informed consent" submission, meaning that it's made with the permission of the MAH, Recordati. It allows RP to submit EMA data under their own drug name/trademark where mutual recognition procedures are in place and to obtain a "certificate of pharmaceutical product" (a comfort factor for the importing country with respect to manufacture, drug strength, pharmaceutical form: CPP is a prerequisite for registration and not a substitute for a full dossier).
The Senstend trademark was granted back 2016. Fortacin is already claimed in China and several other non-Recordati countries and Plethora abandoned the US application a long time ago, and Senstend has been prosecuted in the US, China, Australia and other countries. The Fortacin trademark is registered to Plethora in Hong Kong (since 2018).
Nice to know that POM is still hoping that this dog will eventually have its day (if you are reading this, hope all is good with you). And, was I right or was I right about the rate of uptake in Europe?
interesting bignose thanks.at least it shows some degree of positivity which is welcome.
Indeed. Apparently they required a new entity to hold the duplicate MA so They could obtain a CPP for Senstend so Fosun can register it in China.
As to the Name, I was informed sometime ago (and I think I posted as such) that the product may need to be renamed for some territories.
also notice that it may trade as "plethora solutions(ireland)"
looks as though plethora pharma solutions ltd is a wholly owned subsidiary of plethora solutions ltd(which i am assuming is the same as plethora solutions holdings ltd) so it looks as though they formed the company almost a year ago for this purpose.interesting that its incorporated in Eire.perhaps they expect to makes so much money in China that they want a low tax environment!(?)
I am still a little confused with the company naming being used. Plethora Pharma Solutions Ltd, which I understand was incorporated in Ireland 11 months ago, which is not the same as Plethora Solutions Holding Ltd.
afternoon bignose.sounds like you had a good trip.hope you enjoyed it.thanks for posting and the further investigation (and to P.O.M. for drawing attention).interesting and perhaps potentially very encouraging news.as you say fingers etc crossed!
So,
As I suspected It is really just so data can be “transported” from EMA MAA to the Chinese FDA. Although nothing more was written, it does mean the Chinese must be looking at the data to enable whether a positive outcome/decision regarding testing can be made. Fingers and legs crossed then everybody.... LOL
Morning Guys,
I've just this morning stepped back in from an 8 day trip to Hokkaido in North Japan. Incredible place with much wilderness. They still have many wild brown bears that roam about and each year who invite humans for breakfast, lunch and dinner (fact) - There are so many bears that the numbers have to be controlled by culling. The locals often eat the meat and use their skins for leather goods....... eek.
Anyways, Thanks to POM who brought the following to my attention to:
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/senstend
and
https://www.medscape.com/viewarticle/918810
Nothing to worry about as apparently Senstend is the registered name to be used in China, although I have no idea why it needs to be EMA approved. Could it somehow be related to using the EMA data for the Chinese approval process? I am in the process of trying to get clarification, so watch this space.