Europe – Global regulators commit to cooperate on observational research in the context of COVID-19

Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring.

High-quality observational research is an important complement to the evidence on the safety and effectiveness of vaccines and treatments for COVID-19 generated in randomised clinical trials. It is critical in understanding the safety and effectiveness of medicines when used in clinical practice for the prevention and treatment of COVID-19.

At a second workshop on observational studies of real-world data generated during clinical practice in the context of COVID-19, co-organised by the European Medicines Agency (EMA) and Health Canada under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) on 19 May 2020, international regulators agreed to step up their cooperation in the following three areas…