Swissmedic Annual Report 2021: The second year of coronavirus as a particular challenge

Today the Federal Council approved the Annual Report of Swissmedic, the Swiss Agency for Therapeutic Products, for 2021. It contains an overview of all services provided as well as the annual financial statements. In addition to the varied tasks and support services to combat the coronavirus crisis, Swissmedic continued its normal supervisory activities.

“Switzerland has one of the best-performing therapeutic products authorities in the world”, is the positive verdict of Lukas Bruhin, President of the Swissmedic Agency Council, in the 2021 Annual Report.

The Annual Report illustrates Swissmedic's performance throughout the entire therapeutic product life cycle. Swissmedic not only assesses authorisation applications for medicinal products, but also approves clinical trials with medicinal products, grants official batch releases for vaccines and blood products, and issues establishment licences for medicinal product manufacturers and wholesalers. In addition, Swissmedic is responsible for the market surveillance of medicinal products and medical devices, designates and monitors conformity assessment bodies for medical devices, holds responsibility for monitoring the flow of controlled substances and publishes the official Swiss Pharmacopoeia.

In the second year of the pandemic, Swissmedic was able to authorise the Moderna COVID-19 vaccine within 60 days due to the rolling review process. Alongside authorisation of the Janssen (Johnson & Johnson) vaccine in March, it handled numerous applications for variations concerning shelf life and storage and for the extension of indications to include paediatric age groups and, in the autumn, booster vaccinations. In parallel to this, therapeutic agents such as monoclonal antibodies were reviewed under a rolling submission procedure and authorised temporarily. Market surveillance (vigilance) had to be ensured before the start of the vaccination campaign. By the end of the year, 11,900 reports of suspected adverse reactions to COVID-19 vaccines had been analysed.

In addition to authorisation and market surveillance of medicinal products, Swissmedic also faced challenges in the area of medical devices. As long as the Switzerland-EU agreement on the mutual recognition of certificates of conformity (Mutual Recognition Agreement, MRA) is not updated following the breakdown of negotiations on the institutional framework agreement with the EU, Swissmedic will continue to be excluded from most committees and the European database for medical devices (EUDAMED3). Swissmedic made a considerable contribution to cushioning the possible effects of this on the safety and availability of medical devices with fallback provisions.