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Question on drug approvals in other countries
Posted: Thu Dec 10, 2009 1:21 pm
by patientx
Does anyone know how the drug approval process works in countries outside the U.S.? If a medication is approved by the U.S. FDA, do other countries usually follow suit? I'm wondering, when the oral meds start the receive FDA approval, will that be good enough in other countries, or will they have their own applications and processes?
How did this work after the CRABs and Tysabri received FDA approval?
Posted: Thu Dec 10, 2009 6:11 pm
by oreo
I cannot reply for other countries except my own.
In Canada, the federal government regulates drugs through the department known as Health Canada. They perform a function similar to that of your FDA with respect to drugs.
Like the FDA they have committees which review trial results in order to determine whether or not to approve a drug for use in Canada. Because we have a public health care system, the process here is a little less open to manipulation by big pharma.
For example, when Tysabri was pushing for fast track approval in the US, they also tried here in Canada. The FDA approved fast-tracking and I am sure we all remember how that turned out. In Canada, fast tracking was refused with the result that we didn't see a drug pulled off the shelves after approval because of the PML link.
Posted: Fri Dec 11, 2009 7:06 am
by HarryZ
For example, when Tysabri was pushing for fast track approval in the US, they also tried here in Canada. The FDA approved fast-tracking and I am sure we all remember how that turned out. In Canada, fast tracking was refused with the result that we didn't see a drug pulled off the shelves after approval because of the PML link.
Oreo,
Not only is Health Canada not influenced by big pharma, I've been told that they aren't too impressed with the data that Biogen submits...hence the additional caution.
BTW, I see that your messages have "Carpe Diem" on them. That is the motto of a high school here in London, ON...did you by chance ever attend MTS high school?
Harry
Posted: Fri Dec 11, 2009 4:24 pm
by oreo
Harry,
Nope, grew up in Ottawa.
Oreo
Posted: Sat Dec 12, 2009 4:31 pm
by CureOrBust
I would of expected almost a simple rubber stamp for Australia, however, one of my neuro's recently offered me entry to the (equiv) FTY720 phase III trial. I was surprised as I thought it was up for approval to the FDA already.
I went home and checked, and found a press release from Novartis stating the same, and when I forwarded it to him, his response was "same drug, different company"