Drug approval in other countries

[AndyP]

I'm doing some homework and having problems finding an answer to this scenario:

If I'm a US drug company and I get a US patent and eventual FDA approval, how do I go about getting foreign "FDA" approval? Do other countries recognize the US FDA approval and just let the drug through?

We're just trying to figure out the cost of doing a global launch of our drug in our fake company or not.
Thanks :)

[MannyGoldstein]

1. Clusterfsck

FWIW, I have a bunch of patents and have done FDA filings (that were approved). It's seriously serious stuff.

Other countries are different, both on the patent and regulatory side - they don't recognize our patents or our FDA approvals, although, by being thoughtful, you can do filings that are similar for all countries. The short story is that:
1. This is going to cost a huge amount of money
2. If you're asking questions like this, you need serious assistance

And doing marketing of drugs is also very expensive. The sad truth is that it requires a lot of money be spent - no matter how effective your product is. Pharma companies spend twice as much on sales & marketing as they do on R&D.

[AndyP]

2. I understand that it's expensive

I'm more concerned on an upper level process. I know that for patents I'll need a patent in every country. I'm more concerned with FDA-type approval, will that take the same amount of time for other countries that it does here? Is there a sweeping EU market, or asian market approval?

[MannyGoldstein]

3. I'm Not Sure, But I Think...

I'm fairly certain that Asia is country by country.

I'm not sure on Europe. I think Europe is still country by country, but I know that they've been working towards making things as simple as possible, so there might be an EU-wide process now.

Approval process is generally faster in the EU than in the US. (But marketing in the EU can be much slower)

However, all of this is very dependent on what the drug is, the disease it treats, under what conditions it's prescribed, and so forth. You really need to have an expert work with you on this - I'll try to give you a taste for why:

For example, the FDA and other agencies look at:

1. What you say the drug does
2. Can you demonstrate that the drug does it? (safety)
3. Is the drug safe? (efficacy)

By narrowng claims (what you say the drug does), for example, you might get faster approval, because 2. and 3. might be easier to prove. For example, let's suppose that you have a drug that, if taken everyday, prevents a rare cancer. Doing a study that proves efficacy will take a long, long time - you'll need to have a huge trial and wait years to see what happens (actually, you'll need at least three trials, what are called Phase I, Phase II, and Phase III). And proving safety is tough - it has to be very, very, very safe if health people will be taking it in the hopes of stopping a rare cancer - your drug killing one in 1,000 would be a big problem.

However, if you believe that the same drug might shrink tumors that already exist, you might have a pateh to a much-easier approval - albeit with more-limited claims, and a smaller market. You might even be able to quickly use the drug with people who are about to die of the cancer that you treat under "compassionate use" rules, and collect data quickly. And safety's not as big of an issue - these people are going to die reasonably soon anyway, so killing, say, one in 1,000 with your drug is not so bad, particularly if you save 100 out of 1,000. And after getting approval for the more-limited application, you can go after the larger, preveventative application.

A really good regulatory person can give you the answers pretty quickly. Probably best to call a few and rent an hour of their time to flesh this out.