Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023 10 November 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-6-9-november-2023
Denmark-Questions and Answers on the National Implementation of the EU Clinical Trials Regulation 7 November 2023 All news https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/new-european-clinical-trial-regulation-from-the-31th-january-2022/
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 2 November 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-october-2023
Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 28-31 August 2023 30 October 2023 All news EU-minutes-prac-meeting-28-31-august-2023_27Oct2023-1Download
Early access to medicines: a positive assessment after two years of implementation 27 October 2023 All news Acces-precoce-des-medicaments-un-bilan-positif-apres-deux-ans-de-mise-en-place-du-dispositif-1Download
Benefit-Risk Assessment for New Drug and Biological Products – Guidance for Industry 23 October 2023 All news USA-Guidance-for-Industry-Benefit-Risk-Assessment-for-New-Drug-and-Biological-Products-19Oct-2023-1Download
EMA – Mid-year report 2023 20 October 2023 All news EU-european-medicines-agency-mid-year-report-2023-january-june-2023_18Oct2023-1Download
ANSM – Summary of the 2022 Activity Report 16 October 2023 All news https://ansm.sante.fr/syntheseRA2022FR/index.html#page/1
Feedback on the October 2023 PRAC (25 – 28 September) 13 October 2023 All news https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-doctobre-2023-25-28-septembre
Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting on 03-06 July 2023 9 October 2023 All news EU-minutes-prac-meeting-3-6-july-2023_25Sep2023-1Download
