Version 2 (27/03/2020)
EMA, the European Commission and the Heads of Medicines Agencies updated the Guidance on the management of clinical trials during #COVID19 to cover safety reporting, the distribution of in-vitro diagnostics, medical devices and auditing. The updated guidance also incorporates changes in other sections, in particular on communicating with authorities, informed consent and the distribution of investigational medicines.
The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants
Extraordinary measures may need to be implemented and trials adjusted due to e.g. trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections, and health care professionals being committed to critical tasks. Therefore, EMA, EC and HMA strongly support the efforts of the GCP Inspectors’ Working Group for developing a harmonised EU/EEA-level guidance to mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.