The strategic objectives 2023–2026, which were approved by the Federal Council on 9 December 2022, follow on from the previous strategy period, continue strategic issues where appropriate, and add to them with new focus areas. By contrast, issues that were implemented in recent years, which are now established and dealt with as part of operating activities, are no longer included. This applies in particular to conclusions drawn from the evaluation results of other authorities and the promotion of regulatory systems in low and middle-income countries.
The sector analysis shows the rapid pace of scientific and technological development facing Swissmedic as the authorisation and supervisory authority in the years ahead. New products for which the usual differentiation between medicinal products and medical devices is becoming more difficult, or which, like software, change after market launch, require new forms of regulation. International collaboration between the therapeutic products agencies will increase further. This also applies to surveillance of medical devices, with the lack of an update to the agreement with the EU on the mutual recognition of certificates of conformity (MRA) posing a particular challenge.
Swissmedic is one of the leading therapeutic products agencies worldwide. One of its overarching aims is for Switzerland to continue to have efficient, independent therapeutic products oversight in the future, ensuring that only high-quality, safe and effective therapeutic products are placed on the market in order to protect human and animal health. Greater emphasis will be placed on support for innovation and advancing digitalisation in the new strategy period. Swissmedic will actively support the development of innovative therapeutic products, thereby promoting rapid access to novel therapies for the Swiss population. The latest digital technologies and data-driven work processes enable even more efficient therapeutic products oversight alongside cross-agency and cross-border networking and collaboration. Communication and dialogue with the public remains a key issue.
