New article published on the revised haematological monitoring recommendations for clozapine

Members of the PROGRESS research group were involved in the successful proposal to the European Medicines Agency to relax the haematological monitoring requirements for clozapine. In 2025, the European Medicines Agency (EMA) following a Pharmacovigilance Risk Assessment Committee (PRAC) review, revised routine haematological monitoring recommendations for clozapine. We examine the evidence supporting changes to clozapine haematological monitoring requirements and describe the revised clozapine haematological monitoring recommendations. We include a patient perspective, highlighting a patient’s view of the recommended changes including possible advantages, concerns, and the potential for less burdensome care. This perspective article summarises the regulatory changes, the evidence supporting them, and clinical implications. Key changes include switching to absolute neutrophil count (ANC)-only monitoring, updated ANC thresholds for initiation/continuation. The article can be viewed in full [here].