Simon Tilley ponders the issue of when mass digitalisation and real-world data will accelerate the regulatory process

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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