The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of today, 1 March 2022. It puts some of the structures and processes established by EMA during the COVID-19 pandemic on a more permanent footing, while entrusting several new tasks to the Agency. 

EMA is now responsible for monitoring medicine shortages, which might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU/EEA countries to shortages of critical medical devices and in-vitro diagnostics in crisis situations, after an initial transition period up to 2 February 2023.

Over the next few weeks and months, EMA will set up a number of new bodies and formalise existing ones to manage the new tasks.