MillionMilesAway
Well-Known Member
Is that cost effective? Insofar as I understand it we would have to gain approval either by the FDA or EU or both if we sat outside the regulatory jurisdiction of either area. Would it not make sense to enter into an agreement with either jurisdiction so that both markets can be accessed without unnecessary cost or would not production relocate to either jurisdiction to access both markets? That would leave open the question of access to the UK market I guess.
That's what I said initially, I thought, probably the EU option.
We'll jump in on one side or the other, and copy their regs - "anything that passes EU regs passes UK regs" or something similar.
It may be possible to have both systems and pick and choose, but it confuses things.
Our drugs need to go through EU and FDA to get to market now; they'll still need to do so. I expect we'll just rubberstamp the EU option as being enough. I couldn't tell you how many drugs we have different regs on currently (between the UK and EU).