EMA Releases List of Medical Events for Pharmacovigilance Monitoring

Regulatory NewsRegulatory News | 19 August 2016 |  By 

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.

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 agency's 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.

EMA 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). According to the agency, the IME list contains nearly 8,000 terms and is updated twice annually.

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, EMA's IME 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."

Editor's note: this article originally stated that EMA had released its inclusion and exclusion criteria for its list of important medical events. EMA has clarified that the inclusion and exclusion criteria document had been recently published as part of a document migration.

EMA, Designated Medical Events List (Excel)


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