The European Medicines Agency (EMA) recently presented the European Commission with its first report on assessing the implementation of the EU’s new pharmacovigilance legislation. Pharmacovigilance - the process and science of monitoring the safety of medicines and taking action to reduce potential risks - is vital to public health.
Applied from July 2012, the new EU pharmacovigilance (PhV) legislation aims to offer better promotion and protection of public health through a set of objectives including better collection of key information on medicines, regulatory action to safeguard public health and targeted administrative simplification.
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. Some of the concrete achievements highlighted in the report include:
- 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 several 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.
The legislation was the biggest change to the regulation of human medicines in the EU since 1995 and had significant implications for applicants and for holders of EU marketing authorisations (MAs). The European Medicines Agency (EMA) is responsible
for implementing much of the new legislation, in collaboration with the national competent authorities and the European Commission.