The collaboration between EMA and FDA formally started in 2003 and the two agencies have now almost daily interactions, most of them structured around working groups called 'clusters', some of which include contacts with other international regulators, with the aim to better align, and advance scientific and regulatory excellence worldwide. In the context of the COVID-19 pandemic, the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).