Is there a benefit from the medical literature monitoring service of the EMA?

Abstract

Besides others, literature monitoring is one of the key pharmacovigilance activities performed by the respective MAHs for their products or related product classes to have an early understanding of the newest scientific knowledge or about experiences in the use of their compounds in a real-life setting. For a globally acting organisation, these sources bear several challenges starting with the different languages but also the interpretation of the therapeutic environment where the information come from. Further - with regard to legal obligations - the next challenge is to provide timely information and updates to all respective players in pharmacovigilance like competent authorities or ethics boards. This led global pharmaceutical companies to build a concise and highly efficient system to ensure all such information is appropriately identified, collected, assessed and reported.