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A list of designated important medical events has been developed and provides standardised terms for medical conditions that are serious and usually drugrelated, says the European Medicines Agency (EMA).1
The list contains Medical Dictionary for Regulatory Activities (MedDRA) terms and will be used by the EMA in detecting safety signals. It will enable the EMA and EU Member States "to focus on reports of suspected adverse reactions that deserve special attention, irrespective of statistical criteria...