The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods
Australia-TGA’s risk management approach to the regulation of therapeutic goods_Feb2021
CMDh – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
EU-Practical guidance for procedures related to Brexit_Jan2021
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
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
EU-GVP – Module Risk Minimisation Measures_draft update 01Feb2021
MHRA – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
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
Thirteen new medicines recommended for approval
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.
Australia – Pharmacovigilance obligations of medicine sponsors
https://www.tga.gov.au/pharmacovigilance-obligations-medicine-sponsors
FDA Adverse Event Reporting System (FAERS) Electronic Submissions
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions