The implementation of EMA's full service follows a launch phase which began on 1 July 2015 and which included the 50 most common chemical active substance groups.
Medical literature is an important source of information on suspected adverse reactions to medicines. The European Union's (EU) pharmacovigilance legislation has given EMA responsibility for the monitoring of selected medical literature for a defined list of active substances used in medicines and for entering identified reports of suspected adverse reactions in EudraVigilance, the EU adverse drug reaction collection and management system.
By reducing duplication of reporting from multiple pharmaceutical companies, the initiative will improve the safety monitoring of medicines by enhancing the quality and consistency of data reported in EudraVigilance. It is provided as a service to industry which, for the active substances and literature covered by EMA activities, will no longer be obliged to enter information from the literature, on suspected adverse reactions into EudraVigilance. Individual cases of suspected adverse reactions found in the literature will be made available to marketing-authorisation holders so they can include them in their safety databases and meet their reporting obligations outside the European Economic Area.
Webinars are organised by the Agency for interested stakeholders to support the start of the service. Further information, including a guide, a training video and a document detailing the inclusion and exclusion criteria used by EMA when screening the literature are puplished on the monitoring of medical literature page.
EMA has sent updates on the implementation of its medical literature monitoring service to the qualified persons for pharmacovigilance in pharmaceutical companies as well as to pharmaceutical industry organisations.