List of medicines under additional monitoring
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-november-2021
XEVMPD Data-Entry Tool (EVWEB) user manual
https://www.ema.europa.eu/en/documents/other/extended-eudravigilance-medicinal-product-dictionary-xevmpd-data-entry-tool-user-manual_en.pdf
List of medicines under additional monitoring
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-october-2021
Electronic submission of investigational medicinal product (IMP) data to the Extended EudraVigilance medicinal product dictionary (XEVMPD)
https://www.ema.europa.eu/en/documents/other/electronic-submission-investigational-medicinal-product-imp-data-extended-eudravigilance-medicinal_.pdf
XEVPRM Guidance for sponsors of clinical trials
https://www.ema.europa.eu/en/documents/other/guidance-electronic-submission-information-investigational-medicinal-products-human-use-extended_en.pdf
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-october-2021