- Swissmedic, the Swiss Agency for Therapeutic Products, is a federal public institute and a legal entity in its own right that is independently organised and managed. It has its own budget. Swissmedic is not a federal office.
- Swissmedic carries out economic and safety-related supervisory tasks in relation to therapeutic products and has the power to order administrative measures and conduct criminal prosecutions. In the event of breaches of the Therapeutic Products Act, such as the illegal importing or counterfeiting of medicinal products, it can withdraw licences, close establishments, seize therapeutic products, impose fines and penalties and seek a custodial sentence before the court of law.
- Swissmedic is involved throughout the entire lifecycle of a medicinal product through its work in the areas of licensing, authorisation and market surveillance.
- Guaranteeing safe medicines and medical devices and thereby patient safety in Switzerland is Swissmedic's top priority.
- Based on a review of the documentation submitted by the applicant, Swissmedic decides whether a medicine is safe and effective. If the benefit for humans or animals is greater than the risk, this is known as a positive benefit-risk ratio. Only if this applies, and following a meticulous review, can a medicinal product receive an authorisation to be marketed in Switzerland.
- Swissmedic is responsible for the authorisation of medicinal products and the market surveillance of medicinal products and medical devices, but it is not responsible for cosmetics, food products or nutritional supplements, which are part of the remit of the Federal Food Safety and Veterinary Office (FSVO).
- Swissmedic itself does not manufacture or sell any medicinal products or medical devices.
- Swissmedic can only authorise a medicinal product if an authorisation application has been submitted. The therapeutic products agency is not allowed to ask companies to submit such an application. This separation from industry is of crucial importance for the independent evaluation. However, Swissmedic does help companies by clarifying regulatory issues connected with submitting the application.
- Swissmedic is not responsible for the selling price of a medicine, which is determined on the basis of negotiations between the authorisation holders and the Federal Office of Public Health (FOPH).
- Swissmedic is not responsible for deciding which medicines are paid for by the health insurance schemes. Here, too, the decision is taken by the FOPH.
- Swissmedic does not conduct any studies itself, but is responsible for the authorisation of clinical trials in Switzerland.
Swissmedipedia
The Swissmedic encyclopaedia
Know what matters:
Swissmedipedia
The authorisation of coronavirus vaccines has significantly raised Swissmedic’s profile. But not everyone agrees about what else the Swiss Agency for Therapeutic Products is responsible for, what its objectives are or how it is funded. Swissmedipedia explains what we know and don't know.
- Swissmedic will carry out its own tests in the laboratory if, in connection with market surveillance, counterfeiting or contamination is suspected, or if a federal organisation or international partner authority commissions the accredited Swissmedic Official Medicines Control Laboratory (OMCL) to investigate.
- Before a medical device can be marketed in Switzerland, it must be CE marked. It must also satisfy the requirements of the Swiss Medical Devices Ordinance.
- The authorisation of a medicinal product with a new active substance takes around 400 days. But this does not mean that Swissmedic spends all this time working on an application. The period from the submission of an application to the authorisation of a medicinal product consists of the time required by Swissmedic to review the scientific documentation and the time taken by the applicant to answer questions posed by Swissmedic.
- Swissmedic does not keep any stocks of medicinal products or medical devices. Companies are responsible for supplying Switzerland with therapeutic products (medicinal products, vaccines, medical devices, diagnostic products). The Federal Office for National Economic Supply (FONES) will take action if companies are no longer able to guarantee the supply of important therapeutic products.
- The cantons are responsible for regulating the dispensing of medicinal products and medical devices, including the corresponding licences and monitoring. The Therapeutic Products Act specifies the dispensing categories for medicinal products.
- Swissmedic is financed mostly by fees and levies paid by applicants and authorisation holders. The rest of the funding comes from payments from the federal government for the provision of public services, including legislation or criminal prosecutions and monitoring activities relating to medical devices. Swissmedic's annual budget is made up as follows: 13% from payments from the federal government, 87% from fees and levies.
- Communication and transparency – both with the general public and various other stakeholders – play an important role at Swissmedic. Swissmedic creates transparency with regard to its activities, explains complex issues clearly for patients and provides regular information on its decisions.
- Complementary and herbal medicinal products benefit from various simplified authorisation procedures in Switzerland. In this way, Swissmedic ensures that only safe medicinal products of impeccable quality from this sector are available to patients.
- To be prepared for a future with personalised medicine, novel therapeutic products and digitalised services, Swissmedic networks at national and international level and is driving forward digitalisation within its various sectors. It is also continuously reviewing its existing processes and adapting these when necessary to the rapid scientific and technological development in the healthcare sector. Would you like to find out more? Read the article on ATMPs.