If a drug or medical device has already gone through the regulatory gauntlet at the FDA and Australia, or in the UK and Canada, or the EU and Taiwan, or Switzerland and Singapore, does it seem all that likely that Medsafe’s going to find anything that everyone else missed?
Sure, Medsafe has ‘expedited’ processes for drugs already approved elsewhere. But those processes still impose cost – particularly time cost on pharmaceutical companies’ regulatory affairs teams.
And five million middling-income people at the far end of the world just don’t hit the priority queue. Continue reading “ERIC CRAMPTON: Certified” →