Shaping EU medicines regulation in the post COVID-19 era
Marco Cavaleri, Fergus Sweeney, Rosa Gonzalez‐Quevedo, Melanie Carr
Abstract
The EU Medicines Regulatory Network (EMRN), comprised of the European Medicines Agency (EMA), the medicines regulatory authorities of the Member States and the European Commission (EC), is operating amid a complex crisis that has positioned regulators centre stage due to their key role in the development, approval and safety monitoring of vaccines and treatments for COVID-19. Here we consider the EMA's and EMRN's response to the pandemic and some of the early learnings that will help reshape medicines regulation in the post COVID-19 era. We also reflect on how some of these learnings will be formally followed up under revised EU legislation to extend EMA's mandate, reinforcing its role in crisis preparedness and response.