The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Medical devices do not have an SmPC whilst medicines are not regulated via CEMark. Clear distinctions between devices and medicines. Whilst official bodies may wish to establish their own requirements for either this is distinct from the MHRA. The existing situation highlights that but compare and contrast the amount of paperwork between a new drug and say a pregnancy test kit. The timelines to generate such paperwork are also very different but I can see how you get the two confused.
It's not that 'Porton Down'. There is Public Health England facility on the same site as the Ministry of Defence Science and Technology Laboratories but they are completely separate buildings and organisations.
I should perhaps have more accurately stated "Medicinal product" rather than Medicine. The EMA definition that is used (and inherited by MHRA) is
"A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action."
Hope that is now quite clear.
Ophidian
Hi guys , thank you very much for responses.
Really appreciated.
And if I may , what the bb is for .
Thanks again
Good Luck All
Hmmm a rubber glove which sheaths a rigid digit for a interior anal probing is a class 1 medical device.
I guess for some that is medicine.
They probably supplied the frozen pigs saliva (a batch laced with extra Covid just for their tests!)
Human Medicines, Veterinary Medicines and Medical Devices are simply classes of "Medicines" all of which are administered and regulated in the in the UK by MHRA under a framework of common and class specific guidances and regulations. Whilst New Chemical Entities for example my have additional requirements or standards to be met, the basic overarching framework is the same for all.
Ophidian
The million dollar question is how did Innova’s test pass PD while others haven’t?
MHRA also have a role within Medical Devices such as diagnostics. There activity related to medicines is significantly different and the two shouldn't be confused.
Just to expand a little bit on my explanation - critically...... when you develop a medicine you obviously have to also develop the assays and test methods to be able to measure and assess your medicine. Certaily there are very well defined standards that dictate the limitations as to which techniques are used and how, but the choice of method and how that method is executed resides with the developer. Part of the registration process is an assessment of the method you have developed to assess it's suitability and in particular it's sensitivity, specificity and reproducibility.
The problem Avacta seem to have had and also now apparently Mologic, is that an independent method developed by Porton Down seems to have been used to assess their products, a method which it appears is significantly flawed in it's design and fitness for use. This is a very unusual and troubling departure form normal processes.
Ophidian
Yes as Ophidian says MHRA are for regulation of meds generally, rather like FDA is for the US (though somewhat broader because the F stands for Food). Porton Down's root trace to WW1 when the Germans tried to gas the Btisih forces with chlorine. It was set up to investigate and experiment with both defensive and coutermeasures in chemical warfare and later also biological and even radiological. As you can imagine it has a lot of expertise handling (as well as sometimes misusing) dangerous materials and that is probably why it is being utilised in this situation involving sars cov 2 virus samples.
MHRA are the only Authority who can license a medicine for use in the UK (post Brexit). Porton Down are basically a government laboratory with no regulatory responsibilities for Registration of medicines. HOWEVER just like you can choose if you want to buy Tesco Ibuprofen or Neurofen Tablets based on your assessment of which one you prefer (both are licensed by MHRA for sale in the UK), so too can HMG decide (based on it's Porton Down Lab results) who it prefers to buy COVID LFDs from.
Ophidian
Hi , can someone explain to me the differences between Porton Down and MHRA ?
Such as, which is the higher authority etc
Responses appreciated.