What is the cost of putting a new drug (not innovative) on the market?

[philly]

If I wanted to obtain a marketing authorisation for a medicinal product which is licensed in another EU state, what would be the approximate cost of this? For example, nifuroxazide is available OTC in many EU countries but not in the UK. If my company was to apply for its registration in the UK as a P-medicine, how much money would be needed?

Another, related question: MHRA states that applications for product reclassification can be submitted not only by the MA holder but also any other interested party. I don't understand it. If it was true, my company could apply for reclassification of, let's say, sildenafil, MA of which is held by Pfizer. Does it make sense?

Any information would be appreciated.
Thank you

[johnep]

So what is this med for?
johnep

[philly]

Nifuroxazide? It is a nitrofuran derivative (structure similar to nitrofurantoin) which is used for acute bacterial diarrhoea. I might have not made myself totally clear: I was asking about the total cost, including all the research, expert opinions etc., not just the application cost.

[johnep]

Sounds a bit like entero vioform. Govnmt advice is not to use antibacterials unless proven superinfection. Loperamide for adults and oral rehydration salts really only approved treatment in UK. In the old days we gaily dispensed Sulphatriad, sulphaguanidine, Penbritin KS, Neomin, streptomycin. All swept away by loperamide and ORS.
Entero vioform was popular on the continent but had problems and was withdrawn in UK. No good reason why your med should be any different. I certainly would not consider it.
johnep

[philly]

It was just an example. Let's assume MHRA does agree to grant this med a licence. What would be the cost then? Would it be in the range of a few million, several hundred thousand or less? I know it's a bit tough question but if one can say that to buy a pharmacy you need £700-1500k it should be possible to give an estimate of what I ask about.

[johnep]

So what did the MHRA say when you asked them for an estimate of likely cost?
johnep

[johnep]

Or you could do like Arjun who market products without any licences at all, calling them food supplements or medical devices.
johnep

[philly]

So what did the MHRA say when you asked them for an estimate of likely cost?
johnep

I don't think they know this. They can only tell me what the application fee is.

[Robert]

If I wanted to obtain a marketing authorisation for a medicinal product which is licensed in another EU state, what would be the approximate cost of this? For example, nifuroxazide is available OTC in many EU countries but not in the UK. If my company was to apply for its registration in the UK as a P-medicine, how much money would be needed?

First you'd need to have a registerable dossier. To develop this for a generic generally costs about €30,000 (from scratch and only if it is a simple drug). I'd imagine that nifuroxazide could be cheaper since it is ancient. It'll be a matter of negotiation with the dossier developers. Then, you would have to obtain a license. The fee with the MHRA according to their site is 10,554 pounds for a national license (abridged application, such as a generic). But of course, there are costs involved in the procedure as well. If you were to hire a consultant to do the procedure for you, it'll set you back about 100 pounds per hour (at least, that's what it would probably cost you in the Netherlands, I'm not sure about the UK situation). Then, you would have to have a a manufacturer to make the stuff for you and to release it for the market. Depending on you local legislation, this may mean you yourself would also need a manufacturer's license. I think an initial investment of around 100,000 pounds will go a long way. The more complex the medicine, the more expensive it'll be.

What makes it difficult to predict is that each drug has its own complexity. If you need a drug about which not much is known, it becomes more expensive to develop. For example, if your drug is a biological such as filgrastim, it is much, much, much more expensive than when we're talking a simple, not too heavily regulated small molecule such as acetaminophenol (which is now so cheap to make that it is almost impossible to bring a new brand to the market and make a profit).

Another, related question: MHRA states that applications for product reclassification can be submitted not only by the MA holder but also any other interested party. I don't understand it. If it was true, my company could apply for reclassification of, let's say, sildenafil, MA of which is held by Pfizer. Does it make sense?

Any information would be appreciated.
Thank you

Yes, you could if you can show that you really are an interested party. This is not unusual in administrative law. I am not familiar with the UK situation, but in general, administrative law is such that all interested parties can petition the government for a decision on some matter. In the case of viagra, there are rumours that discussions on its legal status are going on in some countries, especially in southern Europe.
Now that both Actavis and Krka have registered a generic version of sildenafil with the EMA, I expect this discussion to be held broader and perhaps in the CHMP. A major reason for this discussion is probably the enormous amount of counterfeits on sale over the internet, which is dangerous. If the legal status is changed to OTC, this may be a good way to get rid of all those counterfeits.

[Robert]

I don't think they know this. They can only tell me what the application fee is.

Most won't have a clue because most of them have never worked in the industry.