The framework changes the procedure for submitting periodic benefit-risk assessment reports and the analysis by the Agency’s sector dealing with pharmacovigilance. The frequency of presentation of reports, for example, will be carried out by a list published here, on the…
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting.
The ANSM has sent to the Local QPPVs a pharmacovigilance risk-analysis questionnaire to prioritise PV inspections. Pharma companies should complete it by 30th Sep 2020.