The central Swiss Agency for Therapeutic Products, Swissmedic, was founded on 01 January 2002, at the same time the Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act – TPA) entered into force. Before 2002, the individual cantons were responsible for medicinal products. Swissmedic’s main office is situated in Bern and the institute is a public institution that is affiliated to the Federal Department of Home Affairs. Swissmedic aims to ensure that only safe, effective and high-quality medicinal products and medical devices are marketed in Switzerland in order to protect the health of humans and animals in the best possible way. Among others, Swissmedic’s area of responsibility includes:

Approval of Clinical Trials:

Before a medicinal product may be marketed, its safety and efficacy must be tested in several clinical trials. In Switzerland, Swissmedic and the competent ethics committee are responsible for authorizing such clinical trials. Please refer to our blog article for more information about important legislation concerning drugs and medical devices in Switzerland in order to find out which trials must be approved by the responsible cantonal ethics committee and which also require the approval of Swissmedic.

Furthermore, clinical trials involving medical devices belonging to category C must also be approved by Swissmedic and the cantonal ethic committee.

Issuing Licenses:

Apart from the authorisation for the conduct of a clinical trial, a pharmaceutical company also requires a manufacturing license for the investigational product concerned, which is also issued by Swissmedic.

In case of medicinal products that already have a marketing license, companies who are manufacturing or reselling such products must obtain an establishment license, which is granted following a successful inspection by Swissmedic. Also, laboratories working according to the Ordinance on Microbiological Laboratories (SR 818.101.32) must apply for such an establishment license, which must be renewed every 5 years.

Swissmedic also grants special authorisations for obtaining medicinal products which are not approved or out of stock in Switzerland. Medical professionals, such as pharmacists, veterinarians or physicians, who are allowed to dispense medicinal products, may request such special authorization from Swissmedic.

Marketing Authorisation:

Following completion of all necessary clinical trials, Swissmedic will initiate an authorisation procedure to determine whether a new medicinal product intended for use in humans or animals or a medical device may be marketed in Switzerland. Within this procedure, Swissmedic will verify the quality, safety and efficacy of the scientific results. If all requirements are fulfilled the medicinal product or medical device concerned will be granted the authorisation to be marketed in Switzerland.

Market Surveillance:

Swissmedic is also responsible for pharmacovigilance. Following the market launch, Swissmedic assesses national and international reports concerning adverse effects of approved medicinal products. In case a safety risk is detected, medicinal products may be recalled or withdrawn from sale.

Medical devices are also subject to marketing surveillance by Swissmedic: suspicion reports are collected, evaluated and, if necessary, corrective actions from the manufacturer are requested.

Pharmacovigilance:

In order to verify the quality of medicinal products Swissmedic regularly conducts laboratory tests and evaluates national and international reports and recalls products of insufficient quality.