European Commission Publishes Pharmacovigilance Report

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The three-year report emphasizes the roll of collaboration in drug safety.

On August 8, 2016, the European Commission (EC) announced the publication of a

that highlights the collaboration between the European Medicines Agency (EMA), the EC, and European Union Member States in the implementation of pharmacovigilance legislation. The report emphasizes that the collaboration has “enhanced the monitoring of the safety of human medicines throughout their lifecycle, for the benefit of patients.”

The report describes the activities of the EU system for monitoring drug safety from July 2012, when new pharmacovigilance legislation came into effect, until July 2015. According to EMA, the report shows that the new system has been successful at quickly detecting safety issues and is effectively engaging patients and healthcare professionals. EMA stated in a press release that the Pharmacovigilance Risk Assessment Committee (PRAC), a committee dedicated to drug safety, and “the regulatory tools made available under the revised legislation, allow for a more proactive approach to ensuring medicine safety.”


Highlights from the report include:

  • PRAC assesses approximately 600 risk management plans each year for centrally authorized medicines. Approximately 20,000 risk management plans have been submitted to the Member States during the reporting period for nationally authorized medicines.

  • The reporting of side effects has improved. Direct reports from patients have increased by 50%.

  • PRAC investigated nearly 200 safety signals (i.e., information about new or changing safety issues potentially caused by a medicine) up to the end of 2014, which led to updated product information and regulatory measures.

  • Member States evaluated more than 12,000 periodic safety update reports (PSURs) for nationally authorized medicines. PRAC reviewed and finalized more than 900 assessments for centrally authorized medicines, or for active substances found in both centrally and nationally authorized medicines.

  • PRAC led 31 safety-related referrals, which allow for the assessment of the safety or benefit-risk balance of a medicine or a class of medicines.

  • Approximately 200 pharmacovigilance inspections have been carried out every year.

  • New guidance was issued to put focus on medication errors.

  • Side-effect reports related to medication errors increased from approximately 4500 in 2012 to more than 7000 in 2014.

The full

can be viewed on the EC’s website.

Source: EMA