Lessons learnt from the COVID-19 crisis: Regulatory aspects linked to human research and product authorisation

Abstract

The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.