Biovigilance

Biovigilance describes the systematic monitoring, detection, assessment, and prevention of adverse events associated with biological products including vaccines, blood components, and advanced therapies. This framework supports ongoing safety surveillance throughout product use, complementing clinical trial safety evaluation with real-world evidence gathered post-authorisation. Biovigilance activities include adverse event reporting, signal detection, risk management planning, and regulatory communication.

The biopharmaceutical industry implements biovigilance systems to protect patient safety and maintain compliance with global pharmacovigilance requirements. Biological products may present unique safety considerations including immunogenicity, batch variability, and complex mechanisms that require specialised monitoring strategies. Companies establish reporting pathways that capture safety information from healthcare providers, patients, and clinical settings, enabling timely identification of emerging risks. Regulatory authorities expect robust biovigilance plans and continuous safety evaluation, particularly for novel modalities such as gene therapies and cell therapies where long-term follow-up may be required to fully characterise risk profiles and ensure responsible therapeutic deployment.