Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials – Scientific guideline 29 March 2024 All news https://www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-scientific-guideline
ANSM – User guide February 2024 25 March 2024 All news 20240306-le-livret-de-lusager-maj-fev-2024-1Download
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU 21 March 2024 All news https://www.ema.europa.eu/en/news/accelerating-stakeholder-collaboration-enhance-clinical-trials-environment-eu
When you’re pregnant, it’s (always) important to take the right kind of medicine! 19 March 2024 All news https://ansm.sante.fr/actualites/enceinte-les-medicaments-cest-toujours-pas-nimporte-comment
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024 15 March 2024 All news https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-mars-2024-4-7-mars
EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance 11 March 2024 All news Eudravigilance-user-declaration-qualified-person-pharmacovigilance-responsible-person-eudravigilance-1Download
World Health Organization launches a mobile app for biosafety risk assessment 8 March 2024 All news https://www.who.int/news/item/07-03-2024-who-launches-a-mobile-app-for-biosafety-risk-assessment
Pharmacovigilance Risk Assessment Committee (PRAC) – Minutes of PRAC meeting on 27-30 November 2023 4 March 2024 All news EU-minutes-prac-meeting-27-30-november-2023_27-Feb-2024-1Download
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024 1 March 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-february-2024
Medical cannabis: update on the final year of testing and the arrival of cannabis-based medicines 26 February 2024 All news https://ansm.sante.fr/actualites/cannabis-medical-point-detape-sur-la-derniere-annee-de-lexperimentation-et-larrivee-de-medicaments-a-base-de-cannabis