Artificial intelligence workplan to guide use of AI in medicines regulation
https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL))
https://www.ema.europa.eu/en/documents/other/questions-and-answers-describing-adverse-events-product-information-summary-product-characteristics-spc-and-package-leaflet-pl_en.pdf
First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
https://www.ema.europa.eu/en/news/first-version-union-list-critical-medicines-agreed-help-avoid-potential-shortages-eu
EU medicines agencies reflect on lessons learned from COVID-19
https://www.ema.europa.eu/en/news/eu-medicines-agencies-reflect-lessons-learned-covid-19
Relaunched EMA website now live
https://www.ema.europa.eu/en/news/relaunched-ema-website-now-live
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-november-2023
ANSM publishes the 2022 haemovigilance activity report
https://ansm.sante.fr/actualites/lansm-publie-le-rapport-dactivite-dhemovigilance-2022
PRAC recommendations on safety signals
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals