SFAO gives Swissmedic a doubly good report

The Swiss Federal Audit Office (SFAO) conducted audits of two core processes at Swissmedic between November 2022 and July 2023. In both cases, it received very good ratings. The Agency for Therapeutic Products is well positioned for both the authorisation and vigilance of medicinal products, has a very good international network, and has efficient, properly functioning processes that are under constant development. Swissmedic accepts the recommendations, some of which have already been included in its strategic objectives for 2023-2026.

The SFAO's thorough audit of two central processes at Swissmedic yielded results that Swissmedic’s Director Raimund Bruhin is proud of: "The SFAO gave us two very good reports, confirming that we are on the right track. This concerns two areas of activity that ensure the quality, safety and efficacy of medicinal products during approval and later on the market, and are therefore very important for Swiss patients."

Authorisation process for medicinal products

The SFAO audited the authorisation process for medicinal products at Swissmedic between November 2022 and March 2023 with the aim of identifying potential ways of increasing efficiency. In today’s report, the SFAO judged the authorisation processes to be competitive, efficient and functional, and confirmed that Swissmedic continuously optimises the processes and systems and implements the potential identified in a timely manner.

Its national and international cooperation and the parallelisation of processes are suitable ways of tapping into potential efficiencies and enabling them to be utilised, thus ensuring that medicines reach patients more quickly. To do this, all the partners involved in the processes, especially the pharmaceutical companies, must play their part. On the one hand, it is the companies that decide when and where they submit an application for authorisation. On the other, the reimbursement process and therefore also the decision on overlapping or parallel inclusion is the responsibility of the Federal Office of Public Health.

Vigilance process for adverse drug reactions

In its investigation between April and July 2023, the SFAO also attested that Swissmedic's processes, expertise and effectiveness in vigilance – the monitoring of safety through the evaluation of adverse drug reaction reports – are working well, thanks in part to its good national and international networks. The cooperation of medical professionals is required in order to continuously improve patient safety. They must report side effects and take the defined risk-based measures into account in their practice. Swissmedic has repeatedly undertaken initiatives to raise awareness among healthcare professionals, and is also intensifying the exchange of information on the importance of notifications and the legal reporting obligation as part of its strategic objectives.

Swissmedic is already aware of the issues in the SFAO’s recommendations. They are addressed both in the strategic objectives 2023–2026 (Strategic objectives (swissmedic.ch)) and in the report on the “Federal measures for the promotion of biomedical research and technology, 2022–2026” (Boosting biomedical research and technology (admin.ch), and Swissmedic is already working on them in its operational business activities. The Agency’s core mission remains to ensure that the therapeutic products it approves are of impeccable quality, effective and safe.