Swissmedic
From Wikipedia, the free encyclopedia
Swissmedic, the Swiss Agency for Therapeutic Products, is the Swiss surveillance authority for medicines and medical devices, registered in Berne. It started operations on 1 January 2002 as successor of Interkantonale Kontrollstelle für Heilmittel (IKS), which was itself the successor of Schweizerische Arzneimittelnebenwirkungszentrale (SANZ). Swissmedic is affiliated to the Federal Department of Home Affairs.
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[edit] Structure
Swissmedic is a federal institution subject to public law and was created by the Heilmittelgesetz (medicine law).[1] It is independent in organization and management and has authority over its own budget. Its expenses in 2004 amounted to 60 million Swiss francs. 70% were covered by fees taken from industry and 30% by federal funds. Swissmedic has 280 full-time employees.
[edit] Functions
Any medical products for humans or animals need approval from Swissmedic to be brought on the Swiss market. Moreover, Swissmedic must be notified of all clinical studies conducted in Switzerland.
As a rule it takes six months for an application for approval of a product to be appraised, and additional time before the certificate is delivered. Pharmaceutical companies have no influence on the course and outcome of the procedure. Documents from other countries' regulatory authorities are not used, Swissmedic working in an absolutely autonomous way.
Costs of approval are paid by the applicant. Approval must be renewed after five years.
