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.

Meeting participants shared information on ongoing initiatives on COVID-19 observational studies derived from real-world data in various countries and regions around the world. Key learnings from these activities and opportunities for international collaboration were identified. Regulators also discussed the progress made in international cohort building, pregnancy studies, and vaccine surveillance and vigilance during the pandemic.

The meeting built upon the experience and knowledge gained from a series of ICMRA workshops on COVID-19 observational research held in 2020. Participants representing 28 medicines regulatory authorities and experts from the World Health Organization attended the virtual workshop.

The discussion was moderated by Kelly Robinson, Director General of the Marketed Health Products Directorate at Health Canada and Peter Arlett, Head of Data Analytics and Methods Task Force at EMA.

The next ICMRA meeting on COVID-19 observational research is scheduled for April 2021.

Posted on the EMA website on 8 February 2021