CMDh – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP 19 February 2021 All news EU-Practical guidance for procedures related to Brexit_Jan2021
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021 15 February 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-february-2021
EMA consults on revised Risk Minimization GVP module XVI 12 February 2021 All news EU-GVP – Module Risk Minimisation Measures_draft update 01Feb2021
MHRA – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) 8 February 2021 All news https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021 5 February 2021 All news Thirteen new medicines recommended for approval
List of medicines under additional monitoring 1 February 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.
Australia – Pharmacovigilance obligations of medicine sponsors 29 January 2021 All news https://www.tga.gov.au/pharmacovigilance-obligations-medicine-sponsors
FDA Adverse Event Reporting System (FAERS) Electronic Submissions 25 January 2021 All news https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021 18 January 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-january-2021
