The reporting period was from 1 January to 31 December 2021.
EudraVigilance, the European database of suspected adverse drug reaction (ADR) reports, is the tool that the European Medicines Agency (EMA) and national competent authorities (NCAs) use for monitoring the safety of all authorised medicines in the EU as well as medicines studied in clinical trials. Timely detection and assessment of safety signals from sources such as EudraVigilance complements the benefit-risk evaluation of medicinal products via assessment of periodic safety update reports (PSURs) and risk management plans (RMPs) by the Pharmacovigilance Risk Assessment Committee (PRAC).
The database currently holds over 22.3 million individual case safety reports (ICSRs) relating to 12.9 million unique suspected adverse drug reaction case reports1 and is one of the largest pharmacovigilance databases in the world. It has undergone significant development in recent years, and this has delivered enhanced functionalities allowing for a better support of pharmacovigilance activities and the protection of public health.
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