Founded in 2002, Swissmedic regulates the Swiss market for medical products and drugs as Switzerland’s fully independent agency for therapeutic products. Swissmedic is the Swiss equivalent of well-known regulatory bodies such as the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA). This Swizzard Insight No. 1 offers a high-level summary of Swissmedic’s organization, mission and duties (source: www.swissmedic.ch).
Organization
The institute is attached to the Federal Department of Home Affairs, and its activities are governed by the Law on Therapeutic Products. 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. The organization consists of the Agency Council and the Management Board. In order to carry out its legal mandate, Swissmedic collaborates with external national and international stakeholders.
Mission
Swissmedic’s main mission is the authorization and supervision of drugs and medical products to ensure that only high-quality, safe and effective products are available on the Swiss market (Therapeutic Products Act, SR 812.21).
Duties
Core responsibilities encompass a broad range of services including granting establishment licenses, authorizing medicinal products, issuing licenses for manufacturing and wholesale, monitoring the market and approving clinical trials. Swissmedic is involved in the entire life cycle of medicinal products because of its mandated areas of responsibility in the areas of licensing, authorization and monitoring of medicinal products.
The Therapeutic Products Act governs product authorization in detail. Within the framework of the authorization procedure, Swissmedic assesses the quality, safety and effectiveness of the medicinal product in question on the basis of the comprehensive scientific documentation that is submitted. There is an option for an accelerated application procedure for medicinal products for human use, or modifications of existing products.
Companies that manufacture or distribute medicinal or transplant products in Switzerland (manufacturing, wholesale, import, export and trade in foreign countries) require an establishment license. Swissmedic issues this license on the basis of a successful inspection or other evaluation. In addition, persons applying for the import must meet certain minimum standards, e.g. regarding facilities, documentation system and staff members.
Special programs
Swissmedic also offers various special programs in collaboration with the FDA, and helps to improve and accelerate access to health interventions and therapeutic products in low- and middle-income countries.
For further insights, please contact us
Swizzard Pharma AG
Corporate Competence Center
Luc Heller
luc@swizzard-pharma.com