Switzerland To Simplify Cross-Border Inspections

The Swiss Agency for Therapeutic Products (Swissmedic), the national pharmaceutical regulatory authority in Switzerland, reports on new measures, taking effect January 1, 2018, regarding cross-border inspections, including inspections carried out in Switzerland by foreign authorities and inspections by Swiss authorities abroad.

Changes to Switzerland’s Therapeutic Products Act will allow foreign authorities to conduct inspections in Switzerland without obtaining prior permission from Switzerland’s State Secretariat for Economic Affairs. With the new procedure, foreign authorities must notify Swissmedic in advance of their intention to perform an inspection and provide the agency with a copy of the inspection report after they have performed their inspection.

Other provisions provide a legal framework for carrying out inspections abroad. For example, good clinical practice inspections can be carried out abroad even if there is no link to a trial being carried out in Switzerland; i.e. they do not have to be triggered by a preceding inspection, according to information from Swissmedic.

Source: Swissmedic


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