GD decision no. 2024-99 of 25/01/2024 – Changes to the organisational structure of the ANSM
https://ansm.sante.fr/actualites/decision-dg-ndeg-2024-99-du-25-01-2024-modification-de-lorganisation-de-lansm
Clinical trial’s transition to new EU system – one year left
https://www.ema.europa.eu/en/news/clinical-trials-transition-new-eu-system-one-year-left
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-january-2024
Major update of the SME user guide
https://www.ema.europa.eu/en/news/major-update-sme-user-guide
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-janvier-2024-8-11-janvier
Clinical trials on medicinal products: all transition applications must be submitted via the CTIS portal
https://ansm.sante.fr/actualites/essais-cliniques-de-medicaments-toutes-les-demandes-de-transition-doivent-etre-deposees-sur-le-portail-ctis
Q&A: Good clinical practice (GCP)
https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/qa-good-clinical-practice-gcp
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-january-2024
