Guidance on MAH and QPPV location – UK 27 December 2021 All news https://www.gov.uk/guidance/guidance-on-mah-and-qppv-location#history
EMA Management Board: highlights of December 2021 meeting 24 December 2021 All news https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2021-meeting
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021 20 December 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021
PRAC recommendations on safety signals 14 December 2021 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) 10 December 2021 All news Updated on 30 November 2021
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021 6 December 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-november-2-december-2021
FDA Adverse Event Reporting System (FAERS) Electronic Submissions 30 November 2021 All news Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS
List of medicines under additional monitoring 26 November 2021 All news 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 22 November 2021 All news https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf
