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.
In accordance with the principles set out in the Federal Council’s Corporate Governance report, Swissmedic is managed through strategic goals. The Agency Council draws up these strategic goals in accordance with the provisions of the revised Therapeutic Products Act (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.
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.
Its 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.