Hemovigilance: ANSM changes the way blood donors report adverse events 2 January 2024 All news https://ansm.sante.fr/actualites/hemovigilance-lansm-fait-evoluer-la-declaration-des-effets-indesirables-donneurs-de-sang
Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation Version 2 29 December 2023 All news EU-Guidance-for-the-Transition-of-Clinical-Trials-from-the-Clinical-Trials-Directive-to-the-Clinical-Trials-Regulation-Version-2-21-Dec-2023_22Dec2023-1Download
Artificial intelligence workplan to guide use of AI in medicines regulation 26 December 2023 All news https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation 21 December 2023 All news EU-Regulation-EU-2017-745-Questions-and-answers-regarding-clinical-investigation-December-2023Download
Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) 18 December 2023 All news 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 15 December 2023 All news 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 11 December 2023 All news https://www.ema.europa.eu/en/news/eu-medicines-agencies-reflect-lessons-learned-covid-19
Relaunched EMA website now live 8 December 2023 All news 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 4 December 2023 All news 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 1 December 2023 All news https://ansm.sante.fr/actualites/lansm-publie-le-rapport-dactivite-dhemovigilance-2022
