A new concept in Swissmedic’s portfolio

Launched at the end of 2022, the Innovation Office is a new service in Swissmedic’ s portfolio designed to provide faster access to innovative medicines. The idea is to get one step closer to innovators so that small companies and start-ups are supported at an early stage.

The Swissmedic Innovation Office promotes networking and regular dialogue with research institutions and industry.  The aim is to lower the barriers for innovation drivers and to address regulatory challenges in a solution-oriented manner. In our pilot phase, which will last until the end of 2024, we will focus on small players, such as start-ups, spin-offs, research groups and incubators that drive innovation.

The Swissmedic Innovation Office is the central point of contact for all matters related to innovation. It is a small team with a wealth of expertise in advanced therapeutic medicinal products (ATMP): in the current pilot phase, the topics of the Innovation Office are limited to ATMP as defined in Switzerland (cell and gene therapies, siRNA, oligonucleotide products, etc.).

Regulatory feedback

Our aim is to make the Swissmedic Innovation Office a success story through timely product devel-opment support, easy accessibility and simple ways of getting in touch and disseminating regulatory knowledge. Low-threshold advisory services will support those who have concerns about approaching the regulator. The earlier our stakeholders know what the regulatory requirements are, the faster a fruitful outcome can be achieved. And the sooner a mistake is discovered, the more easily it can be corrected so that neither the drug nor the start-up is jeopardised.

The services offered by the Innovation Office include a number of platforms such as on-site meetings with a regulatory and scientific focus. These cover the various stages of drug development and manufacturing, including clinical trials and through to marketing authorisation. The aim is to enable potential applicants to bring their products to market or to assess their clinical application in a timely manner.

We look forward to advising you so that your idea can become a successful product!