EMA literature monitoring service comes into force in September

A medical literature monitoring service run by the European Medicines Agency (EMA) designed to clarify and simplify pharmaceutical companies’ monitoring of active substance side effects will be fully operational by September.

EMA has stressed that 'scientific and medical literature is an important source of information to identify suspected adverse reactions…' Furthermore, it will help streamline existing information flows from pharmaceutical companies about these problems: under EU good pharmacovigilance practice guidelines, marketing-authorisation holders are required to monitor medical literature and to report individual cases of suspected adverse reactions for their medicines. But, said EMA, 'this has led to duplication of efforts by [pharmaceutical companies] for active substances included in more than one medicine, and duplication of reports entered into EudraVigilance and national safety databases'.

EMA’s monitoring work should, it said, improve the efficiency of such reporting; simplify this work for pharmaceutical companies, saving them money; improve data quality by reducing duplicate entries; and support the detection of problems in general.

The EMA service will assess literature on a range of active substance, including herbals, notably active substances contained in medicines with a high number of marketing authorisations.

The medical literature covered is also detailed in a report, which can be accessed here.