EMA Guidance Lists Sponsor Requirements for Completing Periodic Safety Reports

Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency.

Concerns over a report’s completeness can lead to companies being flagged for pharmacovigilance inspections, so data needs to be clear and of high quality, EMA said. The reports should list safety signals, regulatory actions and any changes in an approved product’s risk-benefit profile.

Significant safety actions taken by any country in the world should be reported to the EMA, including: safety-related changes in product labeling, such as restrictions on uses and populations; withdrawal or suspension of a marketing authorization; actions taken in response to defects or quality issues; risk management activities; and inspections in response to safety issues.

Each event should include sufficient details — simply stating that marketing was interrupted is not acceptable.