Drug Safety and Pharmacovigilance Services for EMA

The EMA maintains a system known as EudraVigilance for managing and analyzing information on suspected adverse reactions from medicines in either the clinical trials or in the post-authorization phase. The EudraVigilance database allows for electronic exchange of individual case safety reports (ICSRs), detection of safety signals, and allows for availability of better product information through package leaflets and labeling information. Electronic reporting of side effects and adverse events into the EudraVigilance database is obligatory for all marketing authorization holders (MAH) and sponsors of clinical trials. In addition, all marketing authorization applicants need to submit a risk management plan (RMP) which includes information on the medicine’s safety profile, a pharmacovigilance plan, and a risk minimization plan. Other pharmacovigilance activities that need to be performed by MAH post-authorization includes development of a risk management strategy, incident management plans, medical literature monitoring, reporting of medication errors, submission of periodic safety update reports (PSURs), development of a pharmacovigilance system and pharmacovigilance system master file (PSMF), conduct of imposed or voluntary post-authorization safety studies (PASSs), and detection and management of safety signals.