Pharmacovigilance in the European Union

ABSTRACT

The present article aims to examine pharmacovigilance in the European Union (EU) and to identify the regulatory frameworks across its Member States. In the EU, responsibility for pharmacovigilance lies with the European Commission, the European Medicines Agency, and the authorities of each Member State. Effective pharmacovigilance requires close collaboration among EU Member States, the pharmaceutical industry, health and academic institutions, individual health professionals, and patients. Medicines within the EU undergo rigorous testing and evaluation of their quality, efficacy, and safety before approval at either the Member State or EU level. After market authorization, medicines continue to be closely monitored through ongoing pharmacovigilance activities. The legal framework for pharmacovigilance in the EU is established by Regulation No 726/2004 and Directive 2001/83/EC, which were revised respectively in 2010 (Directive 2010/84/EU) and 2012 (Directive 2012/26/EU). Variations in pharmacovigilance regulatory frameworks among Member States are observed in their pharmacovigilance systems, supervisory mechanisms, reporting of adverse drug events by healthcare professionals and patients, and in the traceability of biological medicines. These differences often result in under-reporting of adverse events, primarily due to lack of awareness and training, insufficient collaboration among stakeholders, and the complexity of adverse event reporting processes. Consequently, several challenges must be addressed, including enhanced training for healthcare professionals, adequate financial resources, and improved adverse event reporting systems, ultimately benefiting European citizens.

Keywords: pharmacovigilance, European Union, regulations, drugs, adverse event