The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) met on 12-15 January 2026 by teleconference.[1] The PRAC is responsible for assessing all aspects of medicines risk management, including the detection, evaluation and communication of adverse reactions.[4] At its monthly meeting, the committee reviewed safety signals, which are information suggesting a new potential causal relationship or a new aspect of a known drug association.[1] Medicines such as niraparib/abiraterone acetate (AKEEGA), finerenone (KERENDIA), entrectinib (ROZLYTREK) and etranacogen dezaparvovec (HEMGENIX) were included in the agenda of the session.[1] The PRAC submits its recommendations on the safety of medicines to the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for the Mutual Recognition of Procedures (CMDh).[4] The results and recommendations from this meeting will be published in the highlights of the meeting after the finalization of individual procedures.[1]