March 2022: Clinical Trials in Human Medicines Update

European Medicines Agency (EMA) updated the page Clinical Trials in Human Medicine over the What’s New Section on March 31, 2022:

The update includes guidelines for the sponsors to manage clinical trials in the situation of war in Ukraine. The European Commission, EMA, and Heads of Medicines Agency (HMA) issued the initial advice for sponsors. It suggests that the sponsor follows the guidelines, approaches, and flexibilities agreed upon during the Covid-19 pandemic. The links for the clinical trial management guidelines during a pandemic are also provided in the update. It also advises sponsors to seek guidance at the national level.

Sponsors can also send a question form to EMA for specific questions about EU guidance. They can also contact EMA or national competent authorities for scientific advice.