Swissmedic inspects clinical trials of medicinal products conducted in Switzerland on a random basis according to defined risk criteria. The inspections focus on whether the safety and personal rights of trial participants are guaranteed. They also verify whether the trials are being conducted in accordance with the scientific criteria for quality and integrity.
Pharmacovigilance inspections (Good Vigilance Practice, GVP) are above all designed to examine compliance with the legally prescribed mandatory reporting of adverse drug reactions in clinical trials as well as spontaneous reports.
Clinical trials associated with the development of human medicinal products can be carried out subject to prior approval. The purpose of GCP inspections is to examine clinical trials at the premises of pharmaceutical companies, contract research organisations (CROs), research organisations or units and trial centres.
Inspections may focus both on the way trial centres are conducting a trial (trial centre inspection) and on the way the sponsor, sponsor's representative or contracted companies are managing it (system inspection). Inspections may examine circumstances relating to one or more clinical trials.
After it has approved a human medicinal product in Switzerland, Swissmedic conducts GVP inspections of marketing authorisation holders (pharmaceutical companies). GVP inspections examine the pharmacovigilance system and processes in place at the inspected companies and service providers contracted by marketing authorisation holders to carry out pharmacovigilance activities on their behalf, and whether these processes comply with the applicable national laws, international pharmacovigilance directives and Swissmedic requirements.