Reporting of serious adverse events and effects, new facts with or without urgent safety measures, and Annual Safety Report 26 March 2021 All news https://ansm.sante.fr/vos-demarches/industriel/declaration-devenements-et-deffets-indesirables-graves-de-faits-nouveaux-avec-ou-sans-mesures-urgentes-de-securite-rapport-annuel-de-securite
EMA – Clinical Trials Information System (CTIS) 22 March 2021 All news https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation
EMA Management Board – highlights of March 2021 meeting 19 March 2021 All news https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2021-meeting
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021 17 March 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-march-2021
Sweden – Apply for clinical trial permit 12 March 2021 All news https://www.lakemedelsverket.se/en/permission-approval-and-control/clinical-trials/medicinal-products-for-human-use/applying-for-a-clinical-trial-permit#hmainbody5
Hong Kong – Notice of requirement on reporting of local drug related safety report, progress report and final study report in clinical trial 8 March 2021 All news HONG-KONG- reporting in clinical trials_Jan2021
EudraVigilance User Manual for MAHs 5 March 2021 All news https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-user-manual-marketing-authorisation-holders_en.pdf
List of medicines under additional monitoring 2 March 2021 All news The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods 26 February 2021 All news Australia-TGA’s risk management approach to the regulation of therapeutic goods_Feb2021
