Clinical trial’s transition to new EU system – one year left 5 February 2024 All news 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 2 February 2024 All news 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 29 January 2024 All news 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 25 January 2024 All news 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 22 January 2024 All news 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) 18 January 2024 All news https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/qa-good-clinical-practice-gcp
Work plan for the Pharmacovigilance Inspectors’ Working Group for 2024-2026 15 January 2024 All news EU-work-plan-pharmacovigilance-inspectors-working-group-phv-iwg-2024-2026_10Jan2024-1Download
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024 12 January 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-january-2024
Midterm report on 2025 network strategy highlights good progress during critical period of the pandemic 5 January 2024 All news https://www.ema.europa.eu/en/news/midterm-report-2025-network-strategy-highlights-good-progress-during-critical-period-pandemic
