Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic. The Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products.
For some years, an increasing number of internationally recognised regulatory authorities have been developing a strategy for better networking with one another. The reasons for this are numerous. The therapeutic products industry is developing and producing medicinal products and medical devices on a global level, and is thus dependent on internationally harmonised standards and regulations. Research and development in the health sector is constantly leading to new findings that must be taken into consideration in the regulatory environment. Politics and society also express certain needs and values with regard to what is expected from a modern, reliable therapeutic products authority that must also be taken into account. Against this backdrop, and in order to guarantee effective protection for the individual patients and for the entire population, in line with the latest status of science and technology, exchange with foreign partners on a variety of topics is essential. For that reason, Swissmedic – together with other internationally recognised authorisation authorities – has built up collaboration at various levels and by means of various instruments, and is constantly seeking to enhance it further.
Swissmedic is endeavouring to achieve harmonisation or alignment regarding the requirements for the authorisation of medicinal products on a bilateral or multilateral level, for example, and is thus contributing towards more rapid access to new, innovative medicinal products and those with known active pharmaceutical ingredients. The Agency is also discussing, in various committees and groups, different aspects related to partner authorities using each other's outputs as a basis, as well as the subject of work sharing. For newly emerging risks related to therapeutic products, i.e. both medicinal products and medical devices, Swissmedic is committed to rapid, timely information exchange and co-ordinates the measures to be taken with other authorities.
To fulfil these tasks and to achieve the ultimate objective of protecting the health of citizens, Swissmedic works as part of an international network. The existing relationships are being increasingly fostered, and new partnerships are being established.
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