Swissmedic, Swiss Agency for Therapeutic Products

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.

Entrance of the Swissmedic main office; Bern, Switzerland
Swissmedic main office

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.

 

Tasks

Swissmedic’s tasks are set out in the TPA and various ordinances. They all focus on protecting human and animal health. Our most important stakeholders are patients, healthcare professionals, politicians, the media, the therapeutic products industry, and authorities and organisations in Switzerland and abroad.

Our core mission comprises key tasks to ensure the safety of therapeutic products throughout their entire life cycle:

  • Authorising clinical trials of medicinal products and medical devices
  • Issuing licences for manufacturing and wholesale trading of medicinal products
  • Authorising medicinal products
  • Carrying out market surveillance of medicinal products and medical devices (quality defects, incidents, illegal trade)
  • Inspecting companies and players in the area of medicinal products and medical devices
  • Performing laboratory testing of authorised and illegally imported medicinal products
  • Prosecuting violations of therapeutic products legislation
  • Drawing up standards
  • Informing the general public and stakeholders
  • National and international cooperation