https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf

Five new medicines recommended for approval

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

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation

https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2021-meeting

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-march-2021

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- reporting in clinical trials_Jan2021

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-user-manual-marketing-authorisation-holders_en.pdf

The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.