Results in persistent or significant disability/incapacity, orīased on these factors, EMA's IME list spells out specific recommendations for including or excluding various types of medical conditions.
Requires inpatient hospitalization or prolongation of existing hospitalization,.According to the agency, the IME list contains nearly 8,000 terms and is updated twice annually.Īccording to ICH, some of the criteria for an adverse event to be considered serious includes any medical event that: 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.ĮMA also maintains a separate list of what it considers to be important medical events (IME) intended to assist with the classification of adverse events based on definitions adopted by the International Conference on Harmonization (ICH). 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.Īccording 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." In recent years, European regulators have initiated a number of new efforts to improve pharmacovigilance after new EU legislation was adopted in 20. The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.ĮMA 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 agency's day-to-day pharmacovigilance activities.
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