Agencies mull use of COVID-19 clinical data in regulatory approach

Global regulators are discussing how data generated during clinical practice could “complement evidence” from clinical trials in COVID-19.

At a dedicated COVID-19 workshop organized by the European Medicines Agency (EMA), the issue was considered by participants representing 28 medicines regulatory authorities, as well as experts from the World Health Organization.

The participants acknowledged the importance of observational studies of real world data in “increasing the effectiveness and efficiency of regulatory processes and decision-making,” as well as for addressing knowledge gaps.