Global advances in biotechnology and personalised medicine are challenging both developers of innovative therapy approaches and regulatory authorities. Patients expect to benefit as quickly as possible from innovative and effective therapeutic products and treatments, but these must be safe and of high quality.
As the Swiss authority responsible for the licensing, authorisation and monitoring of medicinal products, Swissmedic is involved in the entire life cycle of medicines. Created at the end of 2022, the Swissmedic Innovation Office is a new concept in Swissmedic’s portfolio that is designed to achieve faster access to innovative medicines. The idea is to take a step closer to the innovators so that small companies and startups can be supported from an early stage.
Initially, the Innovation Office will restrict itself to advice relating to advanced therapy medicinal products (ATMPs), since Swissmedic is able to act most flexibly in this area. In this way, Swissmedic aims to contribute to strengthening Switzerland as a centre of research by supporting innovation and accelerating the approval process for new products long before they are ready to be placed on the market.
Services provided
Dialogue: initial encounter
The Swissmedic Innovation Office is your first port of call to get answers from our experts on topics such as the planning of clinical trials, production plants or the conditions and documentation required for authorisations.
During the actual pilot phase, support services are restricted to all issues relating to advanced therapy medicinal products (ATMPs).
If you have any questions please don't hesitate to
Dialogue: regulatory advice
The Swissmedic Innovation Office provides, at any stage of development, advice on regulatory requirements and general guidance on issues that need to be considered when developing or testing innovative health products and technologies.
Observance of the regulatory framework from the outset is the way to avoid mistakes that might oth-erwise cause promising treatments to fail due to lack of data or failure to comply with legal requirements.
Dialogue: meet us
The Swissmedic Innovation Office actively approaches research groups, universities, incubators and start-ups. During the pilot phase, we are building a presence at regional innovation hubs and are attending a variety of events about innovative medicines.
Connect with us via one of our points of presence or an event we are attending near you or contact us if you're considering inviting us as speakers to your seminar or workshop.