Press Release: EudraVigilance signal detection methods help detect drug safety issues earlier

EudraVigilance is the European Union database for adverse drug reaction reports. It provides a single repository for all spontaneous reports of suspected serious adverse reactions concerning medicines that are authorised in the European Union received via the national competent authorities for medicines regulation and the pharmaceutical industry.

An evaluation of the use of the European Medicines Agency’s statistical signal detection method in the adverse drug reaction data collected in the EudraVigilance database has shown a significantly earlier detection of drug safety issues in about 54% of cases where a clinically important adverse drug reaction report was found (compared to ‘routine’ pharmacovigilance).

• Primary Source

Website: European Medicines Agency: EudraVigilance http://eudravigilance.emea.europa.eu/highres.htm

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