Posted 01 September 2015
By Zachary Brennan
The European Medicines Agency (EMA) on Tuesday launched its medical literature monitoring service to help identify suspected adverse reactions and reduce the duplication of such efforts by thousands of pharma and biotech companies.
The service, which aligns with guidance in Good Pharmacovigilance Practices (GVP) Module VI, will see EMA monitoring a total of 400 active substance groups, including 300 chemical active substance groups and 100 herbal active substance groups. The list of active substance groups and a reference to the journals covered by the monitoring service are available here.
The latest service comes after the previous system, where drugmakers individually monitored medical literature to report cases of suspected adverse events, led to unnecessarily duplicative efforts tracking the active substances and duplicate reports entered into the EMA safety database known as EudraVigilance, as well as to national safety databases.
The European Union's pharmacovigilance legislation gave EMA the responsibility of monitoring portions of the medical literature for a defined set of active substances and for entering identified reports of suspected adverse reactions into EudraVigilance.
Literature reference databases that will be tracked by EMA include EMBASE, a large and daily-updated and indexed biomedical reference database covering literature from the European Economic Area (EEA) and non-EEA countries; EBSCO, which covers a wide variety of resources; International Pharmaceutical Abstracts (IPA) covering a spectrum of drug therapy and pharmaceutical information from over 800 journals; and the Allied and the Complementary Medicine Database (AMED) covering alternative treatments based on bibliographic records for articles from nearly 600 journals.
"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," EMA said in a statement.
Drugmakers will no longer be obliged to enter information from the literature on suspected adverse reactions into EudraVigilance, and individual cases of suspected adverse reactions found in the literature will be made available to drugmakers so they can include them in their safety databases and meet their reporting obligations outside the EEA.
EMA said the new service will benefit over 4,000 companies, though companies are advised to consult the list on whether their products are covered. Industry stakeholders previously offered comments on the proposed service back in May.
EMA also sent updates on the implementation of its monitoring service to the qualified persons for pharmacovigilance in pharma companies as well as to pharma industry groups, the agency said.