13/03 - CORONAVIRUS and Clinical Trials - Advice requested from EMA

CORONAVIRUS and Clinical Trials - Advice requested from EMA

13 March 2020

In respect to the Coronavirus and the performance of clinical trials, on Friday 13 March 2020, EUCROF has asked the EMA for advice on how to best behave so that clinical trials are not endangered to be considered as GCP non-compliant. See below the letter submitted to Dr Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance & Committees Division at the EMA.                                           

The EMA was thankful for the letter and the questions posed. The EMA stated being already working on the subject and discussing with the GCP IWG. The EUCROF letter was shared with the colleagues involved at EMA, European Commission and Clinical Trial Expert Group. 

EUCROF is waiting for a response and will provide an updated information as soon as available.