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Guidance published during the pandemic has been updated to include content requirements for summary safety reports.
The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) announced on Feb. 11, 2022 the adoption of updated guidance on core requirements for risk management plans of COVID-19 vaccines. Guidance published during the pandemic has been updated to include content requirements for summary safety reports to be submitted to the agency and details on safety topics where monitoring with periodic safety update reports is more appropriate. The updated guidance also includes considerations for frequency changes for summary safety reports and when it is appropriate to no longer submit safety reports.
The updates were made after discussion at PRAC and experience gathered during the pandemic. The revised guidance can be found on EMA’s website.