During its September meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed one ongoing safety referral. It did not initiate or conclude a referral.
The Committee focused on the broad spectrum of its responsibilities which cover all aspects of risk management of the use of medicines. The PRAC’s full range of work includes pre-authorisation activities, such as the assessment of risk-management plans for medicines under evaluation including any studies or risk minimisation activities planned for marketed use. Post-authorisation activities also include risk management planning as well as the evaluation of periodic safety update reports (PSURs) to assess the safety and benefit-risk balance of a medicine throughout its lifecycle. The PRAC also evaluates safety signals, a key public-health function that ensures that new or changing safety issues are rapidly detected, evaluated and, when appropriate, product-labelling changes or restrictions are introduced for the benefit of patients.
Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting in October.