EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that “deserve special attention, irrespective of statistical criteria used to prioritize safety reviews,” and contribute to the agencys day-to-day pharmacovigilance activities.
In recent years, European regulators have initiated a number of new efforts to improve pharmacovigilance after new EU legislation was adopted in 2010 and 2012. These efforts include the creation of the Pharmacovigilance Risk Assessment Committee (PRAC), improvements to the EurdraVigilance database, public pharmacovigilance training courses and a medical literature monitoring service.
According to the agency, the list of so-called designated medical events contains “serious medical concepts often causally associated with drugs across multiple pharmacological/therapeutic classes.”
The 62-item list includes a broad range of medical events that can occur as a result of using various healthcare products, including anaphylactic shock, blindness, hepatic failure, pancreatitis, pulmonary hypertension and ventricular fibrillation.
The agency also released a list of its inclusion and exclusion criteria for what it considers to be important medical events worthy of additional attention.
EMA says the list of inclusion and exclusion criteria was developed by the EudraVigilance Expert Working Group (EV-EWG) based on definitions adopted by the International Conference on Harmonisation (ICH) for serious medical events.
According to ICH, some of the criteria for an adverse event to be considered serious includes any medical event that:
● Results in death,
● Is life-threatening,
● Requires inpatient hospitalization or prolongation of existing hospitalization,
● Results in persistent or significant disability/incapacity, or
● Is a congenital anomaly/birth defect
Based on these factors, EMAs list spells out specific recommendations for including or excluding various types of medical conditions. For instance, under “malignant and occupying processes,” the agency includes “all malignant neoplasms, including metastatic conditions,” but excludes “cysts and polyps (unless qualified as malignant), benign and unspecified neoplasms and neoplasms in remission.”
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