A 4-year overview of pharmacovigilance activities in the EU

A report carried out by the European Medicines Agency (EMA) in collaboration with national competent authorities of European Union (EU) Member States, has shown that the EU pharmacovigilance (PV) system is robust and effective at ensuring the safety of medicines.

The key outcomes reported include:

  • More than 500 new or updated risk management plans were assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) each year, ensuring the safety monitoring and risk minimisation is proportionate and planned. In addition, nearly 7,000 risk management plans were assessed by the Member States for nationally authorised medicines during the reporting period; 
  • Enhanced EudraVigilance database of suspected side effects, resulting in improved reporting and greater analytical power;
  • Evaluation of nearly 9,000 potential signals (information about new or changing safety issues potentially caused by a medicine) by EMA’s signal management team over the period covered by the report, and a similar number of potential signals assessed by Member States; 
  • Radical simplification and improvement of the way periodic safety update reports (PSUR) are handled, by establishing a common repository with a single portal for access;
  • Development of criteria to determine when a public hearing on issues of medicines’ safety would be of value, and the successful holding of the first such hearings, for valproate-containing medicines in 2017 and for quinolone and fluoroquinolone antibiotics in 2018;
  • Continued development of the ‘Article 57 Database’, which now contains information on more than 800,000 medicinal products authorised through central, decentralised, mutual recognition and national procedures across the European Economic Area.

The report, based on quantitative data gathered between 1st January 2015 and 31st December 2018, measured the long term impact of the PV legislation which came into effect in July 2012. The new legislation focused on simplification of PV processes, improved transparency, stakeholder engagement and protection of patient health. To view the full report click here.

Click here to find out what is in store for PV in the next decade.