Confidentiality arrangement between EU and Brazilian regulatory authorities
https://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-brazilian-regulatory-authorities
Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency
https://www.ema.europa.eu/en/documents/other/monitoring-medical-literature-entry-relevant-information-eudravigilance-database-european-medicines_en.pdf
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
Eight new medicines recommended for approval
Important information for pharmaceutical companies regarding electronic pharmacovigilance reporting
https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/info-elektronischen-meldungen-pharmacovigilance.html
EU Individual Case Safety Report (ICSR) Implementation Guide
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-individual-case-safety-report-icsr-implementation-guide_en.pdf
Updated version of 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
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-april-2021
FDA Adverse Event Reporting System (FAERS) Electronic Submissions
Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS.
PRAC recommendations on safety signals
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
List of medicines under additional monitoring
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.