On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”), Switzerland’s Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”), Health Canada, and Singapore Health Sciences Authority (“HSA”).
Earlier, on April 02, 2020, a comparative chart was published summarizing the guidance documents issued by FDA, EMA, MHRA and PMDA.
The comparisons include initiating a new clinical trial, continuing a clinical trial, any changes (amendments) to a clinical trial, informed consent changes, study visits, COVID-19 screening procedures, monitoring
activities, investigational product distribution and study reporting.