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.
Source: EMA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.