Europe – International regulators working together to enhance collaboration on COVID-19 observational research

In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), medicine regulators from around the world emphasised the importance of international collaboration and sharing expertise and best practices on observational studies of real-world data to facilitate regulatory decision-making on COVID-19 treatments and vaccines. The workshop was co-chaired by Health Canada and EMA and took place on 25 January 2021. The main findings of the workshop are summarised in a report, which has been published today. 

As COVID-19 vaccines are being authorised and rolled out across the world, regulators must ensure that their safety and effectiveness is continuously monitored, including when used by special populations such as pregnant women, children and immunosuppressed patients. Real-world evidence generated by observational research is critical to understanding the benefits and risks of medicines for the prevention and treatment of COVID-19 in everyday use by patients and doctors…