The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database.
The service is fully operational as of 1 September 2015.
Scientific and medical literature is an important source of information to identify suspected adverse reactions with medicines authorised in the European Economic Area (EEA).
In line with the guidance in Good Pharmacovigilance Practices (GVP) Module VI, marketing-authorisation holders are required to monitor medical literature and to report individual cases of suspected adverse reactions for medicines for which they hold a marketing authorisation in the EEA. This has led to duplication of efforts by marketing-authorisation holders for active substances included in more than one medicine, and duplication of reports entered into EudraVigilance and national safety databases.
The monitoring of medical literature and the entry of relevant information into EudraVigilance will be carried out by EMA in order to:
- Enhance the efficiency of adverse reactions reporting;
- Provide a simplification for the pharmaceutical industry;
- Improve data quality by reducing the number of duplicates;
- Contribute to resource savings for the pharmaceutical industry;
- Support signal detection activities by national competent authorities and marketing-authorisation holders.