Swissmedic has been conducting GVP inspections in Switzerland since the start of 2013. Before then, pharmacovigilance (PV) systems were reviewed in the course of GCP (Good Clinical Practice) inspections.
The main objective is to verify whether the PV systems of pharmaceutical companies (or contract research organisations/research institutes) conform to legal requirements and GVP recommendations for both authorised medicinal products and clinical trials.
Inspections are usually routine in nature, but can also be triggered by the inadequate quality of Individual Case Safety Reports or relevant findings from earlier inspections, for example.
Last updated on: 02.09.2015