Reporting of local drug related safety report, progress report and final study report in clinical trial – Hong Kong 16 August 2021 All news Hong-Kong-Reporting-of-local-drug-related-safety-report_Aug2021Télécharger
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021 9 August 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-august-2021
Clinical Trial Information System (CTIS) – Sponsor Handbook 6 August 2021 All news https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_en.pdf
China – NMPA National Medical Products Newsletter 2 August 2021 All news China-nmpa newsletter vol IV 2021
List of medicines under additional monitoring 30 July 2021 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021 26 July 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-july-2021
NHS – Safety reporting – UK 23 July 2021 All news https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/safety-reporting/
Clinical trials for medicines: manage your authorisation, report safety issues – UK 19 July 2021 All news Update: Added guidance on how to increase transparency when presenting safety information in the Development Safety Update Report (DSUR)
