The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) held a meeting on November 24-27, 2025, focusing on drug safety and new regulatory actions. The committee reviewed signals, safety updates, and proposed regulatory actions concerning various medications, all essential to improve and maintain the safety of approved medicines within the European Union.
Drug Safety Signals and Reviews
PRAC evaluated several safety signals requiring further investigation. The committee examined cases of brain oedema associated with the use of Yescarta and Breyanzi in treating primary mediastinal large B-cell lymphoma, mandating a comprehensive review from the marketing authorization holders. Cases of cardiotoxicity linked to the antidepressant venlafaxine were also highlighted, leading to a request for a detailed analysis and assessment of patient data related to heart failure and related conditions.
Risk Management and Post-Authorization Studies
Discussions extended to risk management plans for pre-authorization cases, including new drugs for African trypanosomiasis, symptomatic obstructive hypertrophic cardiomyopathy, and COVID-19 vaccines. Post-authorization safety measures were reviewed, leading to updates in reporting and risk minimization strategies for continued market authorization. Moreover, protocols for ongoing post-authorization safety studies (PASS) aimed to reinforce long-term patient safety and drug efficacy were emphasized.
– PRAC emphasized the importance of timely submissions of safety update reports.
– Risk management plans for new pharmaceuticals were assessed to guarantee effectiveness.
– The importance of integrating real-world evidence to support regulatory decisions was noted.
– Enhanced signals monitoring to further curb potential safety risks was highlighted.
The committee concluded that maintaining updated, robust pharmacovigilance systems is pivotal. As drug safety continuously adapts with emerging data, healthcare professionals must stay informed of regulatory updates and new risk management strategies. These meetings play a vital role in ensuring that medicines’ benefits outweigh the potential risks, thereby maintaining public health safety and trust in the medication supply chain. The next PRAC meeting will further address unresolved matters and continued improvements in pharmacovigilance practices.
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