European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 19 November 2021 All news 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 15 November 2021 All news 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 9 November 2021 All news 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 5 November 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 Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021 2 November 2021 All news 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) 29 October 2021 All news 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 25 October 2021 All news 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 22 October 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-october-2021
Highlights of Management Board – October 2021 meeting 18 October 2021 All news https://www.ema.europa.eu/en/news/highlights-management-board-october-2021-meeting
Submission of changes during the clinical trial and reporting on ongoing clinical trials 1 October 2021 All news https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/submission-of-changes-during-the-trial.html
