EMA: Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency

Scientific and medical literature is an important source of information on suspected adverse reaction case reports (also referred to as individual case safety reports). Currently, for active substances included in more than one medicinal product for human use, literature cases are reported in adverse reaction case reports in a duplicative way by marketing-authorisation holders (MAHs) in the European Economic Area (EEA), which is based on their obligation to monitor scientific and medical literature as outlined in the Good Pharmacovigilance Practices (GVP) guideline, Module VI \'Management and reporting of adverse reactions to medicinal products\'.