New EMA guidance on EU periodic-safety-update-report single assessment for nationally authorized medicines

The European Medicines Agency has updated its procedural guidance to ensure that marketing-authorization holders are prepared for the submission of periodic safety update reports (PSURs) for nationally authorized medicines subject to European Union single assessment.

The single assessment of nationally authorized medicines is a deliverable of the 2010 pharmacovigilance legislation. It aims to harmonize and strengthen the review of the benefits and risks of all medicines across the EU. PSUR single-assessment procedures involving a combination of centrally-authorized and nationally-authorized medicines have been in place since April 2013.

All EU PSUR single assessments result in a recommendation from the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).