Swissmedic publishes its Annual Report and financial statements for 2025
Bern, 12.06.2026 — On 12 June 2026, the Federal Council approved the reporting of Swissmedic, the Swiss Agency for Therapeutic Products, for the previous year, thereby discharging the Swissmedic Agency Council of its responsibilities for 2025. It was a year of transition for the Agency, with significant changes at the helm of the organisation and the marked deterioration of the financial situation. The almost 32 million Swiss franc loss in financial year 2025, which is covered by reserves, was the result of a funding shortfall and a sharp rise in costs. Performance in the core business remained consistently high.
There were positive results for five strategic objectives in the third year of the 2023–2026 strategy period. Swissmedic stepped up its supervisory and surveillance activities in 2025. More clinical trials (89) and hospitals (28) were inspected and focus campaigns were conducted to control the use of fillers and audit importers of medical devices. In addition, the Agency again dealt with more than 6,000 cases of illegally imported medicinal products.
Last year, Swissmedic authorised 40 human medicinal products with new active substances, one quarter of which under the international Access and Orbis procedures. The median turnaround time for Swissmedic procedures decreased by 52 calendar days to 392 calendar days. This means the Swiss Agency for Therapeutic Products continues to be among the leading and fastest six regulatory authorities worldwide. In the year under review, 24 veterinary medicinal products were newly authorised, including four vaccines.
Swissmedic further extended collaboration with other authorities and healthcare professionals. It also coordinated a publication pointing out to paediatricians the possibility of importing paediatric medicinal products in the event of supply bottlenecks. The Innovation Office, which was launched in 2023 with a focus on innovative therapies, continued to facilitate dialogue with the regulator in periods of high demand and to promote innovative projects in 2025.
Substantial progress was also made in the area of technical infrastructure. The change in provider from the Federal Office of Information Technology to Swisscom in the second half of the year enabled Swissmedic to commission the private cloud infrastructure. This serves as a platform for various specialist applications. All SAP applications were also successfully transferred to the Swissmedic and SAP cloud. The functions of the Swissmedic Portal were also significantly expanded over several releases. The replacement of the remaining legacy systems will now be implemented more slowly than planned through to 2030.
Swissmedic’s financial situation deteriorated in 2025. The 32 million Swiss franc deficit is due to the increasing shortfall in funding from the federal contribution since 2023, substantial additional operating and staff costs, and the 2022 reduction in the medicinal product supervisory levy. There are three reasons for the additional costs:
- Implementation of stricter medical device regulations and discontinuation of collaboration with the EU;
- Intensified supervisory and surveillance activities and
- The investment required in the digital transformation and in the replacement of IT systems that are reaching the end of their lives but are necessary for providing services.
The Agency Council therefore took decisive measures to improve earnings in November 2025: By 2027, personnel costs will be reduced by 9 percent or 45 full-time equivalents, and material costs will be cut by 19 percent, saving around 6 million Swiss francs.
2025 should therefore mark a turning point. The reserves, which amounted to over 91 million Swiss francs as at the end of 2025, are offset against the loss. Heading into 2026, these reserves still amount to 59.5 million Swiss francs. At the same time, the measures to improve earnings, the 2.7 million Swiss franc increase in the federal contribution for 2027 and the introduction of the device registration fee for medical devices should help to improve the financial situation.
The Federal Council set the course for the future in 2025 with changes at Swissmedic’s helm. It appointed Vincenza Trivigno as the new Executive Director. She took over from Executive Director Raimund Bruhin in January 2026. It also confirmed the composition of the Agency Council and appointed two new members, Milena Folletti and Virginie De Biase, with Monika Rüegg Bless as the new Vice Chair.
Final report on the Transformation of Swissmedic Platforms programme
Swissmedic launched the “Transformation of Swissmedic Platforms” (TSP) programme in line with its strategic objectives in 2022. The IT landscape was outdated, could only be maintained to a limited extent and in some cases had reached the end of its technical life. To replace these legacy systems, the basis for further digitalisation was established under TSP by 2025. The final report on the programme has now been published.
Key technological, technical and organisational foundations were established, particularly through the use of cloud technologies. Core processes in authorisation and licensing were harmonised and data-centric work was further developed with a new technical data model based on international standards. The foundations of the Swissmedic Portal, the future central platform for interactions with stakeholders, are in place. The first application processes are already digitally available. Information security and data protection are strictly regulated. Swissmedic has also established an agile organisational structure with stable product teams.
The remaining legacy systems will gradually be replaced through to 2030 following the Swissmedic roadmap. In future, digital advancement will take place within the standard organisational framework.
The Annual Report and financial statements for 2025 and the final report on the digitalisation programme are available on the Swissmedic website.