Having lots of regulatory qualifications for new drugs makes perfect sense. It’s widely known, however, just how much work goes into each submission and the amount of ‘paperwork’ this creates – albeit virtual paperwork. I’ll never forget a presentation I saw in 2015, showing a submission consisting of 1,485 folders, placed in 375 boxes, weighing a total of over four tonnes!
Let’s also not forget how long it takes the regulators to then sift through each submission before it can go to market. It’s a massively time-consuming process, all driven by the fact that you can’t truly see how well drugs work without rigorous statistical evidence.
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