
Horizon Scanning
Daniel Hürlimann, the man with the telescope
In total, Swissmedic received around 350 applications for new medicinal products in 2024. Each arrived quietly and almost unnoticed. Companies submit their documents for assessment by uploading them to Swissmedic's portal. After that, teams from several departments work on them, sometimes for months. You will search in vain for piles of paper on desks and in corridors these days.
But it's not that long ago that medicinal product applications arrived at Swissmedic by trucks that could be crammed to the roof with paper. "Up to 1500 standard binders full of research results, evidence and forms were submitted for each application", Urs Niggli, Head of the Operational Support Services Division, recalls. One of his team's jobs is to deal with postal traffic between applicants and Swissmedic. They are also in charge of file management – in other words, all the documents that accumulate in connection with authorisations, licences and medicinal product market surveillance. Nowadays these are data rather than paper.
"15 years ago, when an authorisation application arrived by truck, we had to sift through the huge quantities of paper as promptly as possible and archive them forever because that was what the law required", Urs Niggli tells us. It took up to six members of the document management team to unpack the boxes full of files, log them in the system and take a copy of each document to the archive in Zollikofen. Using a slick "trolley logistics" system, they made sure that Swissmedic's reviewers and assessors each got the documents they needed. "It's hard to imagine all that effort these days", says Urs Niggli. That's because digital tools have almost completely replaced paper since Swissmedic started digitalising processes in 2014.
The transformation has also benefited authorisation processes, Urs Niggli tells us. "Thanks to digitalisation, it's taken for granted these days that all teams will be able to access files at the same time and without the time-consuming job of carrying and distributing piles of standard binders throughout the organisation by hand." Nowadays all processes are efficient and transparent, he says, with a digital portal that companies can access at any time to find out the status of their application.
"15 years ago, authorisation applications were truckloads of paper".
Today, the archive in Zollikofen is just a relic of the past. Swissmedic stores 29 kilometres of paper here – two kilometres more than the Bern State Archive. File numbers have risen only slightly since digitalisation, and the "trolley service" ceased in 2016. The administrative files on medicinal products currently available on the Swiss market – 1.5 kilometres in all – have now been digitalised.
Niggli is doubtful that digitalisation is truly sustainable given the huge amount of energy needed for document management.