On 17 October 2018, the Federal Council defined the strategic goals of the Swiss Agency for Therapeutic Products (Swissmedic) for the period 2019–22. Swissmedic guarantees efficient, independent therapeutic products oversight. To fulfil this mandate, the Agency must be able to continue working professionally, self-reliantly, autonomously and efficiently.
Swissmedic is faced with a rapid scientific and technological transformation. Future challenges will arise from areas such as personalised medicine, implementation of the new medicinal products legislation and the impact of digitalisation.
Among other things, the goals stipulate that Swissmedic must constantly renew and expand its competencies so that it can keep pace with developments in its operating environment. The Agency has already digitalised a lot of processes in recent years and has a modern web portal. It will systematically continue to digitalise and exploit the potential of the instruments now in place.
Continuing national and international cooperation
As in the past, international cooperation will play an important role for the Agency. Internationally harmonised standards are essential in this area, since they will permit Swissmedic to make use of other agencies’ results and collaborate with them on review work. The associated activities will be stepped up and the issues will retain their strategic importance.
International cooperation will also include continued support for the development cooperation projects that the Federal Council enshrined in Swissmedic’s service mandate in 2013. Efforts will focus on improving access to therapeutic products by strengthening regulatory systems in low- and middle-income countries (LMICs).
At national level, Swissmedic has stepped up cooperation with authorities and professional associations in recent years. Dialogue with decision makers in the healthcare sector will be further intensified during the next strategy period.
Time-critical processes will also be accelerated in various divisions, including Authorisations, during the 2019–22 strategy period. Activities in recent years have focused primarily on respecting time limits.
From 2002, Swissmedic was managed under a service mandate established by the Federal Council. Now, however, in accordance with the principles set out in the Federal Council’s Corporate Governance report, the revised Therapeutic Products Act (TPA) approved by parliament in spring 2016 stipulates management by strategic goals. The Agency Council draws up these strategic goals in accordance with the provisions of the revised TPA and submits them to the Federal Council for approval. The strategic goals are based on a contextual analysis which the Agency Council has used to prepare a development scenario for the years ahead.
Last modification 02.11.2018