Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021 30 April 2021 All news Eight new medicines recommended for approval
Important information for pharmaceutical companies regarding electronic pharmacovigilance reporting 26 April 2021 All news https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/info-elektronischen-meldungen-pharmacovigilance.html
EU Individual Case Safety Report (ICSR) Implementation Guide 23 April 2021 All news 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 19 April 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
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021 16 April 2021 All news 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 12 April 2021 All news Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS.
PRAC recommendations on safety signals 9 April 2021 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
List of medicines under additional monitoring 6 April 2021 All news The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 2 April 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) 22-25 March 2021 29 March 2021 All news Five new medicines recommended for approval
