The new pharmacovigilance legislation in practice

Recent European legislation has provided new tools to enhance the overseeing of medicinal products in the postmarketing phase. Package leaflets of newly approved medicines contain a black inverted triangle as a signal for enhanced monitoring. The leaflets also have clear instructions on how to report possible adverse drug reactions. Databases of drug reactions are accessible by the public. The most important change is the establishment of the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency (EMA). This Committee will review safety signals of medicinal products arising in the member states of the European Union. The Committee could recommend adaptation of the package leaflet, or suspension or revocation of the marketing authorisation. The PRAC is also involved in the assessment of risk management plans for medicinal products and post-authorisation efficacy and safety studies.</p