Regulating medical devices in the UK
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Guidance on MAH and QPPV location – UK
https://www.gov.uk/guidance/guidance-on-mah-and-qppv-location#history
EMA Management Board: highlights of December 2021 meeting
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
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021
PRAC recommendations on safety signals
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021
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
Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS