EMA Begins Medical Literature Monitoring of APIs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-09-2015 07:10


The European Medicines Agency (EMA) began its full medical literature monitoring service on September 1, 2015. A total of 400 active substance groups (300 chemical active substance groups and 100 herbal active substance groups) will now be monitored by the EMA. The service will benefit over 4,000 companies. The list of active substance groups and a reference to the journals covered by EMA’s medical literature monitoring service are available on the monitoring of the agency's medical literature page. Companies are advised to consult the list to check whether their products are covered by the service.

The implementation of EMA’s full service follows a launch phase which began on July 1, 2015 and which included the 50 most common chemical active substance groups.

The European Union's (EU) pharmacovigilance legislation has given the EMA responsibility for the monitoring of select 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 EMA hopes that 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-authorization holders, so they can include them in their safety databases and meet their reporting obligations outside the European Economic Area.

Webinars will be organized by the EMA 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 the EMA when screening the literature are puplished on the monitoring of medical literature page.

The 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.

Source: European Medicines Agency


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