Monitoring the safety of medicines: European Medicines Agency presents first report on implementation of pharmacovigilance legislation to the European Commission

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02/05/2014

Monitoring the safety of medicines: European Medicines Agency presents first report on implementation of pharmacovigilance legislation to the European Commission

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. The EMA, the national competent authorities in the Member States and the European Commission have collaborated closely in fulfilling their responsibilities for implementing the new legislation.

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

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

  • An increase of more than 9000 in patient reports of suspected adverse drug reactions.
  • Product information changes as a consequence of assessment of signals of new or changing safety issues with certain medicines.
  • Initiation of a number of major public health reviews, for example on :
    • combined hormonal contraceptives and venous thrombo-embolism,
    • medicines containing Cyproterone acetate/ethinylestradiol (Diane-35 and generics) and venous thrombo-embolism,
    • Codeine-containing products (including generics) 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.  By carrying out the tasks highlighted in this report, the EMA contributes to ensuring that the EU system of pharmacovigilance is one of the most advanced and comprehensive systems in the world.

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