GCP and GMP regulatory oversight during the COVID-19 pandemic

ICMRA has published a reflection paper on some of the practices applied by international regulatory authorities during the COVID-19 pandemic to enable remote oversight of good clinical practice (GCP) and good manufacturing practice (GMP) activities. The purpose of this paper is to provide transparency to stakeholders on approaches taken to date during the pandemic.

Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 pandemic (10 December 2021)