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Public Health (02-05-2014)

Monitoring the safety of medicines: European Medicines Agency presents the Commission with its first report

The European Medicines Agency (EMA) has presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation. Responsibility for implementing the new legislation is shared between the European Commission, the national competent authorities and EMA.

The report, which covers the period 2 July 2012 to 1 July 2013, reveals positive results for ensuring the main objectives of the new legislation, i.e. better collection of key information on medicines, improved analysis and understanding of data and information, improved timeliness of procedures, greater transparency, etc.

Some of the concrete achievements during the first-year reporting period are:

  • Nearly 25 000 patient reports of suspected adverse drug reactions - an increase of more than 60% compared to the previous 12 months.
  • Product information changes for medicines following assessment of signals of new or changing safety issues. For example, hearing disorders associated with medicines containing roxithromycin and the risk of hypoglycaemia associated with medicines containing tramadol.
  • Initiation of a number of major public health reviews. For example on:
    • all combined hormonal contraceptives and venous thrombo-embolism,
    • Diane-35 and generics (medicines containing cyproterone acetate/ethinylestradiol) and venous thrombo-embolism,
    • Codeine-containing medicines used for pain relief and overdose in children.
  • Training thousands of individuals in pharmacovigilance, and publication of a catalogue with training material for the implementation of the new legislation.

Pharmacovigilance - the process and science of monitoring the safety of medicines and taking action to reduce their risks - is vital to public health. The report highlights activities that contribute to the EU system of pharmacovigilance being one of the most advanced and comprehensive systems in the world.

Full report available here:

More information on Pharmacovigilance in the EU:

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