Swissmedic

Swissmedic

Logo of Swissmedic

Swissmedic is the Swiss Agency for Therapeutic Products, responsible for the authorization and supervision of therapeutic products in Switzerland. It ensures that only high-quality, safe, and effective therapeutic products are available on the Swiss market. Swissmedic is a key player in the protection of public health in Switzerland.

History

Swissmedic was established in 2002, following the enactment of the Federal Act on Medicinal Products and Medical Devices. It was created to centralize and streamline the regulatory processes for therapeutic products in Switzerland, which were previously managed by various cantonal authorities.

Responsibilities

Swissmedic's main responsibilities include:

• Authorization of Medicinal Products: Swissmedic evaluates and authorizes medicinal products before they can be marketed in Switzerland. This includes both human and veterinary medicines.

• Market Surveillance: The agency monitors the market to ensure compliance with regulatory standards. It conducts inspections and takes action against non-compliant products.

• Licensing of Establishments: Swissmedic licenses establishments involved in the manufacture, wholesale, and distribution of therapeutic products.

• Pharmacovigilance: The agency collects and evaluates reports of adverse drug reactions to ensure ongoing safety of medicinal products.

• Regulation of Medical Devices: Swissmedic oversees the safety and performance of medical devices in Switzerland.

Organizational Structure

Swissmedic is structured into several divisions, each focusing on different aspects of therapeutic product regulation. These include:

• Medicinal Products Division: Responsible for the evaluation and authorization of medicinal products.

• Medical Devices Division: Oversees the regulation of medical devices.

• Market Surveillance Division: Conducts inspections and ensures compliance with regulatory standards.

• Licensing Division: Manages the licensing of establishments involved in the therapeutic products sector.

International Collaboration

Swissmedic collaborates with international regulatory agencies to harmonize standards and share information. It is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Related Pages

• Therapeutic products
• Medicinal products
• Medical devices
• Pharmacovigilance