Swiss Agency for Therapeutic Products (Swissmedic)
Swissmedic – for therapeutic products you can trust
Swissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic Products. As a Federal public law institution with its headquarters in Bern, Swissmedic, the Swiss Agency for Therapeutic Products, is autonomous with respect to its organisation and management, and has its own budget.
Swissmedic is mainly financed by means of fees and to a smaller extent by payments from the Confederation in return for providing services of public utility.
Swissmedic is attached to the Federal Department of Home Affairs. The Agency Council, Swissmedic's strategic decision-making entity, represents its interests before the said Department and the Federal Council. The Agency Council also approves Swissmedic's budget, annual accounts and annual report.
The Federal Council establishes a multi-year service mandate for Swissmedic. This specifies the objectives for the Agency, the services to be provided and the resources made available in order to do so. In addition, the Federal Department of Home Affairs concludes a service agreement with the Agency each year, which covers concrete issues within the mandate.
The wide range of activities are carried out in accordance with both our legal mandate and the needs of the stakeholders. These include patients, the therapeutic products industry, healthcare professionals, authorities and organisations in Switzerland and abroad, and the media.
Their core competencies encompass:
- the authorisation of medicinal products
- licences for manufacturing and wholesale, and inspections
- market monitoring of medicinal products and medical devices
- establishing standards
- clinical trials and laboratory testing regarding the quality of medicines
- national and international co-operation.
Their competence: for therapeutic products you can trust
They are the Swiss authority for the licensing and monitoring of therapeutic products. They perform the mandate conferred upon them by law and work with partner authorities at home and abroad.
They ensure that the therapeutic products they approve are of faultless quality, effective and safe. In doing so they make a significant contribution to safeguarding human and animal health and to maintaining Switzerland's role as a location for business and research.
Respected as an effective supervisory authority for therapeutic products
They perform their mandate reliably and professionally. They observe deadlines set and make consistent decisions. As far as legally admissible, they ensure that their work is transparent. They define the quality of their work and document the results reproducibly.
They perform their the safety of therapeutic products.See more